Sr. Clinical Research Associate - Oncology - FSP
Posted 19 days ago
Job Viewed
Job Description
**Monitoring Responsibilities and Study Conduct:**
+ Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
+ Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
+ During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery
+ Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
+ Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
+ Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level
+ Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies
+ Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution
+ Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
+ Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
+ Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
+ Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
+ Support database release as needed
+ May undertake the responsibilities of an unblinded monitor where appropriate
**Clinical/Scientific and Site Monitoring Risk:**
+ Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
+ Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goals
+ Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
+ Drive Quality Event (QE) remediation, when applicable
+ Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable
**Skills:**
+ Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
+ Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
+ Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
+ Must be fluent in English and in the native language(s) of the country they will work in
+ Ability to travel 60-80%
+ Valid driver's license and passport required
**Education:**
+ Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
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#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Pipeline Medical Manager, Oncology
Posted 12 days ago
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Job Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
Joining AbbVie means you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients' lives. At AbbVie, we conduct groundbreaking science on a global scale every day. AbbVie Canada is one of the Best Workplaces in Canada.
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
About the Role:
AbbVie Canada is seeking an experienced and strategic Pipeline Medical Manager, Oncology, to join our dynamic Medical Affairs team. This pivotal role will lead medical activities for emerging pipeline products, driving the development and execution of impactful Medical Affairs strategies and tactics at key stages, including early brand planning. As AbbVie grows its oncology pipeline, you will oversee and motivate the Canadian pipeline MSL team, support clinical trials, and shape the early evaluation, planning, and pre-launch strategy for pipeline assets, becoming a critical leader in our product development efforts.
Key Responsibilities:
+ Develop and steer the affiliate pipeline plan; contribute to early pipeline assessments, financial long-range planning and modelling, market access, and pre-launch strategies.
+ Provide inspirational day-to-day leadership, coaching, and professional development for the Canadian pipeline MSLs; foster high-performance, collaboration, and strong stakeholder alignment with both global and Canadian objectives.
+ Participate as the medical lead in cross-functional pipeline teams, offering critical expertise and identifying new opportunities for synergy and innovation.
+ Gain field insights, oversee and conduct early market, epidemiological, and business model analyses to inform pipeline and brand planning.
+ Work closely with global marketing, medical affairs, and business intelligence to tailor global pipeline initiatives for the Canadian market and implement early assessment frameworks.
+ Lead/support design, review, and approval of local clinical studies and Investigator Initiated Study contract agreements.
+ Build and maintain relationships with external opinion leaders and relevant clinical groups to facilitate collaboration within medical/scientific programs and pipeline activities.
+ Thrive and adapt within an international, matrixed environment, including travel for cross-affiliate collaboration.
Compliance and Regulatory Responsibilities:
+ Ensure all activities and initiatives comply with relevant Canadian and global regulations, laws, and AbbVie policies, upholding the highest standards of scientific integrity.
+ Support requests for compassionate use or named patient access to AbbVie medications, strictly following regulatory guidelines.
Qualifications
Qualifications:
+ Advanced degree in a relevant scientific discipline (PharmD, MD, PhD).
+ Minimum 5 years' experience in medical affairs within oncology, including solid tumors, hematology, and biomarkers.
+ Demonstrated success in pipeline strategy, early commercialization, and brand planning processes.
+ Deep understanding of drug development and clinical research in oncology.
+ Proven leadership in medical teams and project management; minimum two 2 years experience coaching individuals or teams.
+ Outstanding leadership, teamwork, strategic thinking, and adaptability; ability to influence and work cross-functionally and internationally.
+ Exceptional communication, public speaking, and interpersonal skills.
+ Ability to cultivate strong relationships with external experts and key stakeholders in the oncology pipeline community.
+ Robust organizational and analytical skills, including setting priorities, scheduling, and monitoring project progress and data tracking.
+ Willingness to travel, approximately 30% of the time. Must possess a valid driver's license and passport.
AbbVie strives to provide a French working environment for its employees in Quebec. Although as part of its francization program AbbVie has taken all reasonable steps to avoid imposing the following requirement, advanced knowledge of English / Fluency in English is an essential requirement for the position of Medical Manager, including, but not limited to, for the following reasons:
+ English speaking employees outside the province of Quebec.
+ English speaking clients outside the province of Quebec.
+ Anglophone region outside the province of Quebec.
AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities, and members of visible minorities to apply.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Pipeline Medical Manager, Oncology
Posted today
Job Viewed
Job Description
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job DescriptionJoining AbbVie means you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients' lives. At AbbVie, we conduct groundbreaking science on a global scale every day. AbbVie Canada is one of the Best Workplaces in Canada.
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
About the Role:
AbbVie Canada is seeking an experienced and strategic Pipeline Medical Manager, Oncology, to join our dynamic Medical Affairs team. This pivotal role will lead medical activities for emerging pipeline products, driving the development and execution of impactful Medical Affairs strategies and tactics at key stages, including early brand planning. As AbbVie grows its oncology pipeline, you will oversee and motivate the Canadian pipeline MSL team, support clinical trials, and shape the early evaluation, planning, and pre-launch strategy for pipeline assets, becoming a critical leader in our product development efforts.
Key Responsibilities:
- Develop and steer the affiliate pipeline plan; contribute to early pipeline assessments, financial long-range planning and modelling, market access, and pre-launch strategies.
- Provide inspirational day-to-day leadership, coaching, and professional development for the Canadian pipeline MSLs; foster high-performance, collaboration, and strong stakeholder alignment with both global and Canadian objectives.
- Participate as the medical lead in cross-functional pipeline teams, offering critical expertise and identifying new opportunities for synergy and innovation.
- Gain field insights, oversee and conduct early market, epidemiological, and business model analyses to inform pipeline and brand planning.
- Work closely with global marketing, medical affairs, and business intelligence to tailor global pipeline initiatives for the Canadian market and implement early assessment frameworks.
- Lead/support design, review, and approval of local clinical studies and Investigator Initiated Study contract agreements.
- Build and maintain relationships with external opinion leaders and relevant clinical groups to facilitate collaboration within medical/scientific programs and pipeline activities.
- Thrive and adapt within an international, matrixed environment, including travel for cross-affiliate collaboration.
Compliance and Regulatory Responsibilities:
- Ensure all activities and initiatives comply with relevant Canadian and global regulations, laws, and AbbVie policies, upholding the highest standards of scientific integrity.
- Support requests for compassionate use or named patient access to AbbVie medications, strictly following regulatory guidelines.
Qualifications:
- Advanced degree in a relevant scientific discipline (PharmD, MD, PhD).
- Minimum 5 years' experience in medical affairs within oncology, including solid tumors, hematology, and biomarkers.
- Demonstrated success in pipeline strategy, early commercialization, and brand planning processes.
- Deep understanding of drug development and clinical research in oncology.
- Proven leadership in medical teams and project management; minimum two 2 years experience coaching individuals or teams.
- Outstanding leadership, teamwork, strategic thinking, and adaptability; ability to influence and work cross-functionally and internationally.
- Exceptional communication, public speaking, and interpersonal skills.
- Ability to cultivate strong relationships with external experts and key stakeholders in the oncology pipeline community.
- Robust organizational and analytical skills, including setting priorities, scheduling, and monitoring project progress and data tracking.
- Willingness to travel, approximately 30% of the time. Must possess a valid driver’s license and passport.
AbbVie strives to provide a French working environment for its employees in Quebec. Although as part of its francization program AbbVie has taken all reasonable steps to avoid imposing the following requirement, advanced knowledge of English / Fluency in English is an essential requirement for the position of Medical Manager, including, but not limited to, for the following reasons:
- English speaking employees outside the province of Quebec.
- English speaking clients outside the province of Quebec.
- Anglophone region outside the province of Quebec.
AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities, and members of visible minorities to apply.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit -us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
-us/reasonable-accommodations.html
Global Safety Officer, Oncology

Posted 3 days ago
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Job Description
**What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.**
Making a positive impact on patients' lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.
**About Us:**
We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.
**In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.**
We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.
From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.
**Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.**
**Purpose and Scope**
Global Safety Officer is accountable for proactive safety surveillance of Astellas drug products, both those in development and marketed products, including leading PV Product Responsible Teams as a pharmacovigilance specialist, ensuring the medical safety for the assigned compounds or products, contributing to an optimal benefit/risk profile and responsible for the design and successful implementation of signal management and risk management strategies for assigned products.
**Essential Job Duties**
+ Leads PV Product Responsible Teams for assigned products, co-chairs Global Development Safety Management Teams, and participates in Global Development Core Teams and Global Medical Affairs Core Medical Teams as the pharmacovigilance specialist, ensuring the medical safety of products for the assigned Global TA and contributing to an optimal benefit-risk profile.
+ Responsible and accountable for the timely identification and communication of emerging safety issues and safety updates of the Company Core Data Sheet, Investigator's Brochure and local product labeling. This also includes responsibility for effective and regular communication with the Global TA Group Lead and with the applicable QPPV.
+ Responsible and accountable for the design of safety surveillance strategies, management of safety signals for Astellas drug products, both those in development and marketed products, for the collection and identification of safety signals using safety data for signal surveillance activities, categorization and prioritization of safety signals and for authoring, medical review and, as appropriate, approval of safety evaluation reports (SERs), working closely with Safety Science.
+ Responsible and accountable for the risk management of assigned Astellas drug products, both those in development and marketed products, the development and submission of the Risk Management Plan (RMP) and for the execution of risk management strategies in collaboration with internal and external stakeholders, working closely with Safety Science.
+ Responsible and accountable for timely and high-quality contribution to periodic and ad hoc (e.g. Health authority requests) safety reports for assigned products in terms of authoring and review of medical sections, the overall medical-scientific analyses and conclusions.
+ Responsible and accountable for the ongoing monitoring and assessment of the safety profile of assigned Astellas developmental and marketed products as a member of study teams and for representing PV in the design, conduct, analysis and reporting of Phase 1 - Phase 3 clinical trials and Post-Authorization Studies.
**Required Qualifications**
+ Bachelor's degree required; advanced professional degree in scientific, health-related field (e.g. PharmD or PhD) strongly preferred (pharmaceutical industry experience in a relevant therapeutic area preferred);
+ Minimum of at least 6 years of experience with M.D., D.O., PhD, or PharmD degree, and at least 8 years of experience with bachelor's or master's degree, in the pharmaceutical industry and/or a relevant health science setting (such as academia). Direct exposure to pharmacovigilance functions, additional regulatory and/or clinical development experience is a plus.
+ In-depth understanding of safety regulations for both marketed and investigational products, and excellent knowledge of regional and global authority requirements, including ICH, and other applicable requirements, able to influence decisions relating to patient safety and assessment of benefit-risk.
**Preferred Qualifications**
+ M.D. strongly preferred (board certification in medical specialty or pharmaceutical industry experience in a therapeutic area preferred).
**Additional Information**
Astellas Pharma Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the hiring process.
Astellas Pharma Canada requires full Vaccination against COVID-19 as a condition of employment. Reasonable accommodation to this policy may be granted for a valid accommodation request under human rights legislation.
_No telephone inquiries, in-person applications, or agencies please. While we appreciate all applications, only candidates under consideration will be contacted._
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Category Medical Safety Science
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Therapeutic Area Head, Oncology
Posted today
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Job Description
Job Description
Company Description
Ergomed is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.
Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia
Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.
We have nourished a true international culture here at Ergomed.
We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient’s lives.
Job DescriptionAs the Therapeutic Area Head Oncology, you will play a crucial role in driving the success of new business proposals, as well as clinical trial delivery by combining medical/scientific expertise, standard of care knowledge, awareness of emerging therapeutic trends, a patient-centric focus, and regulatory expertise. You are the titular therapeutic expert in oncology across the entire organization, and as such you are involved in all efforts to optimize our commercial and operational success in oncology. You are highly visible to both internal and external stakeholders in generating and communicating thought leadership at internal Ergomed forums, academic and industry symposia, publications, as well as digital promotions.
- Key medical/scientific leader responsible for the oncology input informing the corporate strategy of Ergomed CRO
- Serve as the Head of the Ergomed Oncology Center of Excellence leading therapeutic and operational subject matter experts providing innovative medical and therapeutic insights to sponsors
- Advocate for patient care and safety, as well as for the sponsor organization, while upholding standards of quality and ensuring that clinical operations remain financially viable
- Collaborate with internal and external experts to incorporate innovative approaches and industry best practices into oncology trial design and planning
- Work closely with Business Development to contribute medical/scientific insights and thereby enhance Ergomed's ability to win new business opportunities in oncology
- Develop and present compelling narratives that highlight Ergomed's expertise and unique approach to prospective clients, effectively demonstrating the value of our strategic solutions in oncology
- Leverage your comprehensive understanding of oncology therapy clinical development, incorporate the sponsor context, therapy characteristics, disease indications, scientific/medical knowledge, and regulatory requirements, to support the design of strategic plans for successful trial outcomes
- Stay updated with the latest medical advancements, industry trends, and regulatory requirements, ensuring compliance and driving innovation
- Provide mentorship, guidance, and development support to Operations team members involved with oncology clinical trials, enhancing their capabilities and expertise
- Conduct oncology disease-specific training to Medical Affairs staff so that they are fully aware of the medical considerations needed to support drug safety for the given clinical trial
- Support the Clinician Engagement function to gather insights from key opinion leaders in diverse geographic regions, to better inform our understanding of the standard of care, the clinician/investigator experience, the attractiveness of the scientific endpoints under investigation, and the viability of the protocol design
- Partner with the full gamut of cross-functional operational colleagues to predict, identify, mitigate, and manage potential challenges and issues that arise during study execution
- Represent Ergomed by attending industry meetings, speaking engagements, participating in booth exhibitions, professional associations, public forums, etc, and by publishing scientific or industry related articles in peer-reviewed medical journals
- Establish Ergomed as a recognized authority in oncology clinical research within the broader pharmaceutical and clinical research landscape
- MD or PhD (MBA also preferred)
- Expertise and extensive clinical research experience in oncology on a global basis.
- Strong and broad network of key stakeholders and KOLs in oncology around the world.
- Previous experience in a CRO environment, with a proven track record of driving significant oncology business growth.
- In-depth knowledge of Regulatory Authority regulations and strong understanding.
- Strong leadership and communication, verbal, and presentation skills.
- Effective organizational, presentation, documentation, and interpersonal skills.
- Strong business acumen and proven ability to navigate in a complex matrixed global environment.
- Ability to manage multiple tasks to meet deadlines in a dynamic environment.
- Solutions provider; converts challenges to opportunities.
Additional Information
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
Training and career development opportunities internally
Strong emphasis on personal and professional growth
Friendly, supportive working environment
Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join!
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
We look forward to welcoming your application.
Associate Medical Director- Genitourinary Oncology
Posted 15 days ago
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Job Description
Medical Affairs Group
**Job Sub** **Function:**
Medical Affairs
**Job Category:**
People Leader
**All Job Posting Locations:**
Toronto, Ontario, Canada
**Job Description:**
We are searching for the best talent for our **Associate Director, Medical Affairs, Genitourinary Oncology** position, located in Toronto, Ontario, Canada.
**About Oncology:**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at Associate Director, Medical Affairs, Genitourinary Oncology is responsible for providing Medical and scientific leadership to a cross-functional team. This role is responsible and accountable for providing leadership as well as high level, evidenced-based, clinical and scientific expertise to internal and external partners, support cross-functional teams identifying barriers and opportunities and implementing medical affairs tactics and initiatives. The successful candidate will lead Evidence Generation Processes in collaboration with the therapeutic area team and in direct communication with the global organization. This person will provide leadership and support for evidence generation activities including local Phase IV clinical studies and Investigator Initiated Studies. The Associate Director will also work closely with external sites to ensure flawless integration of the new assets into the health care system.
**Responsibilities include, but are not limited to:**
+ Lead the development and execution of the medical strategy for Genitourinary Oncology aligned to the brand strategy
+ Serve as the internal medical authority on Genitourinary Oncology, providing disease area knowledge across the organization
+ Contribute to the development of TA plans, including drug launches, lifecycle management and indication expansions
+ Build and maintain strong relationships with external partners including; key opinion leaders (KOLs), medical societies and academic and community institutions
+ Represent the Genitourinary Oncology business in scientific exchanges and advisory boards to gather insights to inform strategy
+ Provide support to market access, regulatory and patient engagement internal partners
+ Lead and be responsible for the planning and execution of a data generation plan to support the business inclusive of investigator initiated studies, real-world evidence projects and collaborative research
+ Serve as a member of the cross-functional brand team (including commercial, market access, regulatory, etc)
+ Partner with global medical and clinical teams to adapt international strategies to the Canadian context
+ Provide medical review and approval of promotional and non-promotional materials in accordance with PAAB/IMC codes
+ Provide high-quality, balanced medical information to internal teams and external customers
+ Develop and deliver training to field-based teams on disease stake, clinical data and product positioning
+ Ensure all medical activities follow relevant laws, regulators, industry codes and company standards
+ Provide mentorship and leadership to direct reports, junior medical affairs staff and medical science liaisons
+ Contribute to a high-performing medical affairs culture, grounded in scientific integrity and patient-centricity
+ Identify and explore opportunities to drive business and process efficiency
**Requirements:**
+ A minimum of a Master's degree is required. PhD, PharmD or MD degree is an asset.
+ Background in Oncology or Genitourinary Oncology (Bladder/Prostate) is preferred.
+ People management experience is preferred.
+ 5+ years relevant experience in a multinational pharmaceutical industry.
+ Experience developing and implementing medical drug launch strategies to ensure successful incorporation into the healthcare industry.
+ Strong background in clinical research from protocol writing to execution is an asset.
+ Excellent written and verbal communication skills, with both scientific and lay audiences, are required.
+ Proven track record developing, presenting, and publishing clinical studies is preferred.
+ Strong leadership skills and the ability to work with, and motivate a team is preferred.
+ Strong project management skills and ability to impact decision-making with relevant partners based on sound scientific knowledge.
+ Bilingualism in English and French is an asset.
+ This position requires up to 25% annual travel (domestic and international travel)
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via or contact AskGS to be directed to your accommodation resource.
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Registered Practical Nurse - Medicine Oncology
Posted today
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Job Description
Company Description
One of Canada's Best Diversity Employers and Greater Toronto's Top Employers for many consecutive years, William Osler Health System (Osler) provides a safe and supportive health care network to grow your career. Osler is nationally recognized for its commitment to patient safety and is Accredited with Exemplary Standing, the highest rating a Canadian hospital can receive. As a major Ontario hospital system, and home to some of the biggest specialty and emergency departments in the country, Osler serves the 1.3 million residents of Brampton, Etobicoke and surrounding communities. We are proud to offer you incredible exposure to best-in-class health care delivery and challenging hands-on opportunities to stay at the top of your game.
A hospital system built for and by the community, we continue to expand our services to meet the needs of a growing population, creating opportunities for increased hands-on skills development, cross-department training and promotional opportunities. Guided by our accomplished senior leadership team, together we are driving our vision of world-class health care inspired by our people and communities.
At Osler, we invest in careers that go beyond where health care professionals like you can achieve their goals and find deep personal and professional fulfillment. Join our team today!
Job DescriptionThe Registered Practical Nurse (RPN) is a regulated health care professional who is accountable and responsible for providing quality patient focused nursing care to patients who are identified as less complex, demonstrate more predictable outcomes and are at lower risk for negative outcomes in the Oncology and Palliative Department. As part of the inter-professional health care team, the RPN will practice according to the nursing practice expectations set by Osler, the regulatory practice standards of the College of Nurses and the legislative requirements set by the Regulated Health Professions Act.
Accountabilities:
- Safe nursing practice in all aspects of the nursing process: assessment, planning, implementation and evaluation of patient care
- Professional, patient-centred care to ensure patient safety and physiological and psychological well-being
- Providing care in a compassionate and caring manner within a diverse cultural environment
- Practicing according to the infection control and prevention measures
- Responding to emergency situations by recognizing changes in patient's health status and consulting appropriately when necessary using transfer of accountability principles
- Providing health teaching to patients and families including thorough discharge instructions to ensure the continuity of care in the community
- Recent experience within the last five years palliative and oncology nursing experience required
- Proficient in core competencies for palliative care including pain assessment tools (palliative performance sale and Edmonton symptom assessment system) required
- Palliative Care certificate or Certified Hospice Palliative Care Nurse certificate required or acquired within one year of hire
- Foundation in oncology nursing practice course required or successful completion acquired within one year of hire
- Must have an in-depth understanding of the physiological nature of cancer and its effect on the human state
- Recent experience in care of patient with TPN, NG tubes, chest tubes, tracheostomy, wound care, enteral feeds, IV therapy, blood collection and isolation
Core competencies:
- Current registration, and in good standing, with the College of Nurses of Ontario
- Sound knowledge of nursing process, theory, and responsibilities to the nursing profession
- BCLS required
- Medication Administration certificate and patient assessment course required for RPNs graduating prior to 2005
- Demonstrated excellent interpersonal, communication, problem-solving, conflict-resolution and decision-making skills required
- Demonstrated ability to work collaboratively as a member of an inter-professional team
- Demonstrated knowledge of patient and family-centred care
- Demonstrated experience with patient and family health teaching required
- Demonstrated leadership and facilitation skills required
- Demonstrated excellent customer service, organizational and critical-thinking skills required
- Demonstrated commitment to continuous learning and professional development as it applies to the profession and related field
- Demonstrated ability to work in a stressful environment
- Exemplary clinical practice within an inter-professional team to develop appropriate strategies for patient care
- Ability to prioritize patient care needs and make autonomous decisions
- Excellent physical assessment skills required
- Ability to promote a healthy work environment and practice excellent client safety guidelines
- Knowledge and understanding of the Occupational Health and Safety Act
- Must demonstrate Osler's Values of Respect, Excellence, Service, Compassion, Innovation and Collaboration
- May be required to travel and work between all Osler sites
- Excellent attendance, punctuality and work record
Additional Information
Hours: Currently days, nights, 8 and 12 hour shifts including weekends and statutory holidays (subject to change in accordance with operational requirements)
Salary:
Minimum: $35.29 per hour
Maximum: $38.16 per hour
Internal application deadline: (October 9, 2025)
#LI-SC1
Osler values inclusivity and diversity in the workplace. We welcome and encourage applicants from diverse backgrounds. We are committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act. If you require an accommodation at any stage of the recruitment process, please notify Human Resources at
While we thank all applicants, only those selected for an interview will be contacted. Any information obtained during the course of recruitment will be used for employment recruitment purposes only, and not for any other purpose.
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Registered Practical Nurse - Medicine Oncology
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Job Description
Company Description
One of Canada's Best Diversity Employers and Greater Toronto's Top Employers for many consecutive years, William Osler Health System (Osler) provides a safe and supportive health care network to grow your career. Osler is nationally recognized for its commitment to patient safety and is Accredited with Exemplary Standing, the highest rating a Canadian hospital can receive. As a major Ontario hospital system, and home to some of the biggest specialty and emergency departments in the country, Osler serves the 1.3 million residents of Brampton, Etobicoke and surrounding communities. We are proud to offer you incredible exposure to best-in-class health care delivery and challenging hands-on opportunities to stay at the top of your game.
A hospital system built for and by the community, we continue to expand our services to meet the needs of a growing population, creating opportunities for increased hands-on skills development, cross-department training and promotional opportunities. Guided by our accomplished senior leadership team, together we are driving our vision of world-class health care inspired by our people and communities.
At Osler, we invest in careers that go beyond where health care professionals like you can achieve their goals and find deep personal and professional fulfillment. Join our team today!
Job DescriptionThe Registered Practical Nurse (RPN) is a regulated health care professional who is accountable and responsible for providing quality patient focused nursing care to patients who are identified as less complex, demonstrate more predictable outcomes and are at lower risk for negative outcomes in the Oncology and Palliative Department. As part of the inter-professional health care team, the RPN will practice according to the nursing practice expectations set by Osler, the regulatory practice standards of the College of Nurses and the legislative requirements set by the Regulated Health Professions Act.
Accountabilities:
- Safe nursing practice in all aspects of the nursing process: assessment, planning, implementation and evaluation of patient care
- Professional, patient-centred care to ensure patient safety and physiological and psychological well-being
- Providing care in a compassionate and caring manner within a diverse cultural environment
- Practicing according to the infection control and prevention measures
- Responding to emergency situations by recognizing changes in patient's health status and consulting appropriately when necessary using transfer of accountability principles
- Providing health teaching to patients and families including thorough discharge instructions to ensure the continuity of care in the community
- Recent experience within the last five years palliative and oncology nursing experience required
- Proficient in core competencies for palliative care including pain assessment tools (palliative performance sale and Edmonton symptom assessment system) required
- Palliative Care certificate or Certified Hospice Palliative Care Nurse certificate required or acquired within one year of hire
- Foundation in oncology nursing practice course required or successful completion acquired within one year of hire
- Must have an in-depth understanding of the physiological nature of cancer and its effect on the human state
- Recent experience in care of patient with TPN, NG tubes, chest tubes, tracheostomy, wound care, enteral feeds, IV therapy, blood collection and isolation
Core competencies:
- Current registration, and in good standing, with the College of Nurses of Ontario
- Sound knowledge of nursing process, theory, and responsibilities to the nursing profession
- BCLS required
- Medication Administration certificate and patient assessment course required for RPNs graduating prior to 2005
- Demonstrated excellent interpersonal, communication, problem-solving, conflict-resolution and decision-making skills required
- Demonstrated ability to work collaboratively as a member of an inter-professional team
- Demonstrated knowledge of patient and family-centred care
- Demonstrated experience with patient and family health teaching required
- Demonstrated leadership and facilitation skills required
- Demonstrated excellent customer service, organizational and critical-thinking skills required
- Demonstrated commitment to continuous learning and professional development as it applies to the profession and related field
- Demonstrated ability to work in a stressful environment
- Exemplary clinical practice within an inter-professional team to develop appropriate strategies for patient care
- Ability to prioritize patient care needs and make autonomous decisions
- Excellent physical assessment skills required
- Ability to promote a healthy work environment and practice excellent client safety guidelines
- Knowledge and understanding of the Occupational Health and Safety Act
- Must demonstrate Osler's Values of Respect, Excellence, Service, Compassion, Innovation and Collaboration
- May be required to travel and work between all Osler sites
- Excellent attendance, punctuality and work record
Additional Information
Hours: Currently Days/Nights, 8 and 12 hour shifts including weekends and statutory holidays (subject to change in accordance with operational requirements)
Salary:
Minimum: $35.29 per hour
Maximum:$38.16 per hour
Internal application deadline: (October 13, 2025)
#LI-SC1
Osler values inclusivity and diversity in the workplace. We welcome and encourage applicants from diverse backgrounds. We are committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act. If you require an accommodation at any stage of the recruitment process, please notify Human Resources at
While we thank all applicants, only those selected for an interview will be contacted. Any information obtained during the course of recruitment will be used for employment recruitment purposes only, and not for any other purpose.
Medical Director - Hematology/Oncology - Remote U.S/Canada

Posted 3 days ago
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Job Description
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
**Summarized Purpose:**
Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports (e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labelling reconciliation documents, CTD modules, REMS, RMP and CSR).
**General Support:**
Ensures tasks delegated to pharmacovigilance are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to PPD's corporate policies and SOPs/WPDs. Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately. Provides therapeutic training and protocol training on assigned studies, as requested. Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns. Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete. Contributes to departmental process improvement initiatives.
**Clinical Trial Support:**
Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies. Discusses all medical concerns with principal investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study. Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites
**Marketed Products Support:**
Manages signal detection activities, scientifically reviews aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities. Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted.
**Education and Experience:**
+ MD required with specialization/formal training in Oncology or Hemato-Oncology (active medical license and board certifications are preferred, but not required).
+ Clinical experience in treating patients associated with the applicants training (comparable to 2 years) **and one** of the following:
+ Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or
+ Direct experience in safety/Pharmacovigilance medical monitoring (comparable to 2 years).
_In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role._
**Knowledge, Skills and Abilities:**
+ Therapeutic expertise across one or more medical specialty or sub-specialties (one being Oncology or Hemato-Oncology)
+ Excellent interpersonal skills, influencing and team building skills
+ Understanding of guidelines (FDA, ICH, EMA and GCP)
+ Working knowledge of biostatistics, data management, and clinical operations procedures
+ Ability to act as a mentor/trainer to other staff within pharmacovigilance
+ Strong, well supported decision-making, problem solving, organizational skills and analytical skills
+ Excellent oral and written communication skills
+ Working knowledge of relevant safety databases (e.g. MedDRA)
+ Flexibility to travel domestically and internationally for short periods
+ Ability to work independently, analyse work with attention to detail, process and prioritize sensitive complex information
+ Proficiency in computer productivity applications (e.g. word processor, spreadsheets and presentations) required
+ Fluent in spoken and written English
+ Capable of multitasking and good organization skills
**Working Conditions and Environment:**
+ Work is performed in an office environment with exposure to electrical office equipment.
+ Occasional drives to site locations with occasional travel both domestic and international.
**Physical Requirements:**
+ Frequently stationary for 6-8 hours per day.
+ Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
+ Frequent mobility required.
+ Occasional crouching, stooping, bending and twisting of upper body and neck.
+ Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
+ Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
+ Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
+ Frequently interacts with others to obtain or relate information to diverse groups.
+ Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
+ Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
+ Regular and consistent attendance.
**Benefits:**
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Attaché de recherche clinique II, Oncologie /Clinical Research Associate II, Oncology

Posted 3 days ago
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Job Description
**Aperçu du poste**
Surveiller et gérer les centres pour s'assurer qu'ils réalisent les études et produisent des rapports sur les données d'étude conformément au protocole d'étude, aux règlements et aux lignes directrices applicables, et aux exigences du promoteur.
**Fonctions essentielles**
+ Effectuer des visites de surveillance du centre (visites de sélection, d'initiation, de surveillance et de clôture) conformément à la portée des travaux indiquée au contrat et aux bonnes pratiques cliniques.
+ Travailler avec les centres pour adapter, piloter et suivre le plan de recrutement des sujets conformément aux besoins du projet afin d'améliorer la prévisibilité.
+ Administrer le protocole et la formation sur les études connexe dans les centres assignés et établir régulièrement la communication avec les centres pour gérer les attentes et les problèmes en cours de projet.
+ Évaluer la qualité et l'intégrité des pratiques du centre d'étude liées au bon déroulement du protocole et au respect de la réglementation applicable. Signaler les problèmes de qualité, le cas échéant.
+ Gérer l'avancement des études assignées en suivant les soumissions et les approbations réglementaires, le recrutement et l'inscription, l'achèvement et la soumission du cahier d'observation (CRF), ainsi que la production et la résolution des requêtes de données. Apporter son appui pendant la phase de démarrage, au besoin.
+ S'assurer que les copies/originaux (selon les besoins) des documents du centre sont ajoutés au dossier principal d'essai (DPE) et vérifier que le dossier du centre de l'investigateur (DCI) est conservé conformément aux BPC et aux exigences réglementaires locales.
+ Créer et maintenir une documentation appropriée concernant la gestion du centre, les résultats des visites de surveillance et les plans d'action en soumettant des rapports de visite réguliers, en générant des lettres de suivi et d'autres documents d'étude requis.
+ Collaborer et assurer la liaison avec les membres de l'équipe de l'étude pour le soutien à l'exécution du projet, le cas échéant.
+ Le cas échéant, soutenir l'élaboration du plan de recrutement des sujets du projet pour un centre donné.
+ Le cas échéant, superviser la gestion financière du centre conformément à l'accord d'essai clinique signé et récupérer les factures conformément aux exigences locales.
**Diplômes et expérience**
+ Baccalauréat dans une discipline scientifique ou en soins de santé exigé
+ Au moins 2 ans d'expérience en surveillance sur place.
+ Une combinaison équivalente d'études, de formation et d'expérience peut aussi être acceptée.
+ Bonne connaissance et aptitude à appliquer les exigences réglementaires applicables en matière de recherche clinique.
+ C'est-à-dire les lignes directrices des bonnes pratiques cliniques (BPC) et du Conseil international d'harmonisation (CIH).
+ Bonne connaissance des thérapies et protocoles, tels que présentés dans la formation en entreprise.
+ Compétences informatiques, y compris la maîtrise de Microsoft Word, Excel et PowerPoint et de l'utilisation d'un ordinateur portable ainsi que d'un iPhone et d'un iPad (le cas échéant).
+ Maîtrise écrite et verbale de l'anglais et du français
+ Solides compétences en matière d'organisation et de résolution de problèmes.
+ Gestion efficace du temps et des finances.
+ Capacité à établir et à entretenir des relations de travail efficaces avec les collègues, les gestionnaires et les clients.
+ Vous devrez soutenir, assurer la liaison avec et/ou travailler avec des (clients et/ou fournisseurs) d'IQVIA partout au Canada et à travers le monde, par conséquent, une connaissance fonctionnelle de l'anglais, tant à l'écrit qu'à l'oral, est nécessaire à l'exercice des fonctions de ce poste.
___
English:
IQVIA is seeking a Clinical Research Associate II with Oncology monitoring experience based in Eastern Canada. Must be bilingual in French and English.
**BASIC FUNCTIONS:**
Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA t0 ensure all monitoring activities are conducted according to study requirements. This position may also serve as Lead CRA.
**II ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**
+ Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
+ Collaborates with the ISSC department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISSC and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
+ Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
+ Trains site staff on the EDC system and verifies site computer system.
+ Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISSC.
+ Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.
+ Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
+ Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.
+ Perform SAE review and reconciliation
+ May review protocols, eCRFs, study manuals and other related documents, as requested by Clinical Trial Manager and/or Lead CRA.
+ Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
+ Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
+ May assist with, and attend, Investigator Meetings for assigned studies.
+ Attends study-related, company, departmental, and external meetings, as required.
+ May serve as mentor for new clinical study monitors.
+ Authorized to request site audits due to data integrity concerns.
+ Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.
+ Ensure all study deliverables are completed per IQVIA Biotech and study timelines.
**LEAD CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:**
The Lead Clinical Research Associate **may** perform any of the following tasks:
+ Participate in the investigator recruitment process. Perform site evaluation visits, as needed, of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
+ Collaborate with the ISSC department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISSC and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
+ Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
+ Assists with, and attends, Investigator Meetings for assigned studies.
+ Train site staff on the EDC system and verify site computer system.
+ Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISSC.
+ Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.
+ Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
+ Review the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Work with sites to resolve data queries.
+ May review draft protocols, eCRFs, monitoring reports and follow-up letters, study manuals and other prepare study-related documents and templates, as requested by the CTM and/or PM.
+ May serve as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
+ Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions.
+ Assist the study management in identifying and generating changes in scope
+ Perform study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
+ Authorized to request site audits due to data integrity concerns.
+ Attend study-related, company, departmental, and external meetings, as required.
+ Ensure internal and study-related trainings are completed per IQVIA Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.
+ Ensure all study deliverables are completed per IQVIA Biotech and study timelines
+ Conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs.
+ Serve as mentor for junior CRAs and those new to the company and/or study.
+ Participate in the performance appraisal program by providing timely and accurate feedback regarding the performance of a perspective CRA.
+ Review and approve CRA travel expenses and time sheets.
+ Perform other duties, as requested.
**KNOWLEDGE, SKILLS AND ABILITIES:**
+ Knowledge of clinical research process and medical terminology.
+ Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
+ Good organizational and interpersonal skills.
+ Ability to reason independently and recommend specific solutions in clinical settings.
+ Ability to understand electronic data capture including basic data processing functions.
+ Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.
+ Ability to qualify for a major credit card, rent an automobile
**PHYSICAL REQUIREMENTS:**
+ Very limited physical effort required to perform normal job duties
+ Extensive use of telephone and face-to-face communication requiring accurate perception of speech
+ Extensive use of keyboard requiring repetitive motion of fingers
+ Regular sitting for extended periods of time
**MINIMUM RECRUITMENT STANDARDS:**
+ BS/BA/BSc (or equivalent) in one of the life sciences or health care background (RPh, RN, etc.) and a minimum of two (2) years of monitoring/site management experience is required; or an equivalent combination of education, training and experience.
+ Must possess 2+ years of oncology and/or medical device experience.
+ Experience in monitoring and/or coordinating clinical trials required.
+ Must be able to travel domestically approximately 65%-85%.
+ Valid driver's license
+ Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
+ You will be required to support, liaise with and/or work with IQVIA customers and/or suppliers across Canada and around the world therefore, a functional knowledge of English, both written and spoken, is necessary to perform the duties of this position.
Comme nos équipes de recrutement sont mondiales, veuillez soumettre votre CV en anglais et en français.
As our hiring teams are global, please submit your resume in both English and French.
IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se consacre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez est fière d'être un employeur souscrivant au principe de l'égalité d'accès à l'emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l'orientation sexuelle, l'identité de genre, l'origine nationale, le handicap, l'âge, l'état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d'adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure d'adaptation, nous vous encourageons à contacter notre équipe d'acquisition de talents au , afin qu'IQVIA puisse soutenir votre participation au processus de recrutement.
Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA uniquement pour aider notre équipe de recrutement à sélectionner ou à évaluer les candidatures, et non pas pour remplacer la prise des décisions par les membres de notre équipe.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation, we encourage you to contact our Talent Acquisition Team at: , so that IQVIA can support your participation in the recruitment process.
Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidacies, and not as a substitute for human decision-making.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
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