331 Data Manager jobs in Canada
Global Data Manager
Posted today
Job Viewed
Job Description
Job Description
The Global Data Manager works collaboratively with the business and department leads to maintaining organizationu2019s data with quality and proper references. This role is based onsite out of our Mississauga office location and reports to the Global Director, IT Strategy and M&A. The focus of this role is to:
Oversee the organizationu2019s data systems and ensure the integrity, accessibility, and security of our data assets.
Development and implementation of data related processes such as Data Governance, Data Quality, Data Security, and Data Compliance.
Data Migration and Conversion tasks for ERP implementations
Benefits
Health Insurance (includes Virtual Health, and HCSA)
Dental Insurance
Vision Insurance
Life Insurance
Long-term Disability
Short-term Disability
RRSP Match
Paid Vacation
Floating Days
Employee Assistance Program
Employee Engagement Events
Awards and Recognition
Tuition reimbursement
Service Awards
Employee Perks & Discounts
Job Responsibilities
Data Governance
Ensure organizationu2019s data is accurate, secure, and used responsibly.
Design and maintain a data governance strategy, policies, and standards.
Defines roles and responsibilities related to data ownership and stewardship.
Collaborates with data stewards, and business units to enforce data governance policies.
Develop dashboards and reports to track governance KPIs.
Provide regular updates to senior leadership on data governance initiatives.
Align data governance with broader data strategy and digital transformation goals.
Evaluate and recommend tools and technologies to support governance efforts.
Data Quality
Develop and implement strategies for maintaining and optimizing the organization data quality processes based on best practices.
Manage data quality projects by understanding the business strategies, priorities and challenges.
Asses current data quality capabilities to come up with appropriate solutions and deliver the expected value.
Identify opportunities for Data Quality improvement initiatives with business partners to address data quality challenges including execute data correction activities; engage correct business teams who may need to update their business process to mediate data quality issues.
Establish data quality metrics and monitor compliance.
Lead initiatives to improve data accuracy, completeness, and consistency.
Data Conversion
Responsible for developing standards, guidelines, processes and expertise to convert data from legacy ERP systems into enterprise ERP platforms.
Monitor recurring exception reports and initiate data clean-up opportunities.
Establish Standardized Processes, Procedures and Tools for the conversion of data.
Perform data mapping between ERPs platforms.
Reporting and Measurement of the conversion of data
Work with end users on standardization opportunities.
Use knowledge of the system to help develop better efficiencies within the system.
Cleansing and Normalization of the Data
Data duplication checks and Cross-Referencing
Prepare Master and Transactional Data load files and/or manually input the changes directly into ERP system.
Data Oversight
Collaborate as one of final approver for global master data as per the MDM workflow processes.
Ensures data practices comply with regulations (e.g. GDPR, CCPA, HIPAA).
Identify and mitigate data-related risks across the organization.
Oversees the management of metadata and master data to ensure consistency.
Support the creation and maintenance of data catalog and dictionaries.
Escalation points for Global Master Data Issues
Develop and monitor Global Data Key Process Indicators (KPIs) to monitor trends and identify improvements.
Develop and monitor Global Data Quality Key Process Indicators (KPIs) to monitor data quality trends and identify improvement.
People Management
Provide people care for the future global team of DG and DQ analysts in North America and Europe
Ensure future DG and DQ Analysts performance targets align with organizational and department goals.
Performance Management for all future DG and DQ analysts
Develop and deploy training plans for future DG and DQ analysts.
Define the Data organization and manage recruitment for future Data positions.
Ensure that department level goals are achieved.
Qualifications
Minimum of 15 years of overall IT experience in data management, master data, data quality, data governance, and metadata management
Strong proficiency in database management systems (e.g. Oracle, SQL Server, etc.)
Proficiency on data visualization tools (e.g. Power BI, Tableau, etc.)
Strong understanding of data governance frameworks and compliance standards.
Expert with data quality concepts and process improvement methods
Solid knowledge of data governance and cataloging tools (e.g. Collibra, Alation, Informatica Axon, Microsoft Purview, etc.)
Experience with data analysis tools and reporting software, MDM software preferably Informatica IDQ
Knowledge of master data management and governance leading practices
Experience with project management methodologies and tools.
Ability to develop and prepare technical specifications and documentation.
Experience working with ERPs including JDE, SAP, Business Central and Dynamics 365
Experience working with the manufacturing and/or building industries is desired.
Excellent analytical, planning, and organizational skills.
Exceptional written, verbal, communication, and presentation skills with the ability to articulate innovative ideas and concepts to technical and nontechnical audiences
Bacheloru2019s degree in business, computer science, computer engineering, electrical engineering, system analysis or a related field of study, or equivalent experience
25% estimated travel across North America and Europe
#LI-SM2
Benefits of Employment: IKO recognizes that its success is due to the strength of its employees. A primary goal of IKO is to promote individual employee''s sense of accomplishment and contribution so that employees enjoy their association with IKO. The Company invests in its employees so that they are the most knowledgeable in the industry, and undertakes great efforts to nurture loyalty to, and teamwork at, IKO. We are pleased to offer competitive compensation, health care, a progressive and challenging workplace and a commitment to teamwork and integrity.
Diversity and Equal Opportunity Employment: IKO Industries Ltd. is an equal opportunity employer. We are committed to diversity and inclusion and are pleased to consider all qualified applicants for employment without consideration to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, veteran status or disability. IKO Industries Ltd. encourages and welcomes applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.
Global Data Manager
Posted today
Job Viewed
Job Description
Job Description
The Global Data Manager works collaboratively with the business and department leads to maintaining organizationu2019s data with quality and proper references. This role is based onsite out of our Mississauga office location and reports to the Global Director, IT Strategy and M&A. The focus of this role is to:
Oversee the organizationu2019s data systems and ensure the integrity, accessibility, and security of our data assets.
Development and implementation of data related processes such as Data Governance, Data Quality, Data Security, and Data Compliance.
Data Migration and Conversion tasks for ERP implementations
Benefits
Health Insurance (includes Virtual Health, and HCSA)
Dental Insurance
Vision Insurance
Life Insurance
Long-term Disability
Short-term Disability
RRSP Match
Paid Vacation
Floating Days
Employee Assistance Program
Employee Engagement Events
Awards and Recognition
Tuition reimbursement
Service Awards
Employee Perks & Discounts
Job Responsibilities
Data Governance
Ensure organizationu2019s data is accurate, secure, and used responsibly.
Design and maintain a data governance strategy, policies, and standards.
Defines roles and responsibilities related to data ownership and stewardship.
Collaborates with data stewards, and business units to enforce data governance policies.
Develop dashboards and reports to track governance KPIs.
Provide regular updates to senior leadership on data governance initiatives.
Align data governance with broader data strategy and digital transformation goals.
Evaluate and recommend tools and technologies to support governance efforts.
Data Quality
Develop and implement strategies for maintaining and optimizing the organization data quality processes based on best practices.
Manage data quality projects by understanding the business strategies, priorities and challenges.
Asses current data quality capabilities to come up with appropriate solutions and deliver the expected value.
Identify opportunities for Data Quality improvement initiatives with business partners to address data quality challenges including execute data correction activities; engage correct business teams who may need to update their business process to mediate data quality issues.
Establish data quality metrics and monitor compliance.
Lead initiatives to improve data accuracy, completeness, and consistency.
Data Conversion
Responsible for developing standards, guidelines, processes and expertise to convert data from legacy ERP systems into enterprise ERP platforms.
Monitor recurring exception reports and initiate data clean-up opportunities.
Establish Standardized Processes, Procedures and Tools for the conversion of data.
Perform data mapping between ERPs platforms.
Reporting and Measurement of the conversion of data
Work with end users on standardization opportunities.
Use knowledge of the system to help develop better efficiencies within the system.
Cleansing and Normalization of the Data
Data duplication checks and Cross-Referencing
Prepare Master and Transactional Data load files and/or manually input the changes directly into ERP system.
Data Oversight
Collaborate as one of final approver for global master data as per the MDM workflow processes.
Ensures data practices comply with regulations (e.g. GDPR, CCPA, HIPAA).
Identify and mitigate data-related risks across the organization.
Oversees the management of metadata and master data to ensure consistency.
Support the creation and maintenance of data catalog and dictionaries.
Escalation points for Global Master Data Issues
Develop and monitor Global Data Key Process Indicators (KPIs) to monitor trends and identify improvements.
Develop and monitor Global Data Quality Key Process Indicators (KPIs) to monitor data quality trends and identify improvement.
People Management
Provide people care for the future global team of DG and DQ analysts in North America and Europe
Ensure future DG and DQ Analysts performance targets align with organizational and department goals.
Performance Management for all future DG and DQ analysts
Develop and deploy training plans for future DG and DQ analysts.
Define the Data organization and manage recruitment for future Data positions.
Ensure that department level goals are achieved.
Qualifications
Minimum of 15 years of overall IT experience in data management, master data, data quality, data governance, and metadata management
Strong proficiency in database management systems (e.g. Oracle, SQL Server, etc.)
Proficiency on data visualization tools (e.g. Power BI, Tableau, etc.)
Strong understanding of data governance frameworks and compliance standards.
Expert with data quality concepts and process improvement methods
Solid knowledge of data governance and cataloging tools (e.g. Collibra, Alation, Informatica Axon, Microsoft Purview, etc.)
Experience with data analysis tools and reporting software, MDM software preferably Informatica IDQ
Knowledge of master data management and governance leading practices
Experience with project management methodologies and tools.
Ability to develop and prepare technical specifications and documentation.
Experience working with ERPs including JDE, SAP, Business Central and Dynamics 365
Experience working with the manufacturing and/or building industries is desired.
Excellent analytical, planning, and organizational skills.
Exceptional written, verbal, communication, and presentation skills with the ability to articulate innovative ideas and concepts to technical and nontechnical audiences
Bacheloru2019s degree in business, computer science, computer engineering, electrical engineering, system analysis or a related field of study, or equivalent experience
25% estimated travel across North America and Europe
#LI-SM2
Benefits of Employment: IKO recognizes that its success is due to the strength of its employees. A primary goal of IKO is to promote individual employee''s sense of accomplishment and contribution so that employees enjoy their association with IKO. The Company invests in its employees so that they are the most knowledgeable in the industry, and undertakes great efforts to nurture loyalty to, and teamwork at, IKO. We are pleased to offer competitive compensation, health care, a progressive and challenging workplace and a commitment to teamwork and integrity.
Diversity and Equal Opportunity Employment: IKO Industries Ltd. is an equal opportunity employer. We are committed to diversity and inclusion and are pleased to consider all qualified applicants for employment without consideration to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, veteran status or disability. IKO Industries Ltd. encourages and welcomes applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.
Clinical Data Manager
Posted 7 days ago
Job Viewed
Job Description
**What you will be doing:**
* Participates in study level vendor oversight activities. May represents data management function on the
Clinical Sub-team ensuring aligned expectations between the CRO and clientfor all data related deliverables,
especially in support of key decision points and regulatory submissions.
* Serves as a first point of contact for CROs partners when collaboration is needed to ensure established
milestones and deliverables are met with the highest degree of quality.
* Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
* For studies where data management activities are conducted within client, leads and manages clinical trial
data collection set-up, data review, and database lock:
(a) Works with other functions to complete set up of EDC and other study data collection tools such as IRT,
ePRO and eCOA.
(b) Leads the creation and maintenance of study data cleaning plan components, including edit checks (data
validation plan), listing review checks, data integration specifications, data transfer specifications, external data
reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans.
(c) Leads data review, including query management, and leads activities required for interim and final
database locks.
* Participates in preparing function for submission readiness and may represent function in a formal inspection
or audit.
* Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
* Tracks study deliverables and evaluates study metrics to mitigate risk for major data management
deliverables and milestones.
* Responsible for the planning and management of external Data Management budgets and timelines to ensure
accuracy, understand trends in variances and support continuous improvement in forecasting.
* May prepare metrics to support the function's KPIs.
* Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to
identify industry best practice and increase the visibility of client.
* Contributes to functional Continuous Improvement initiatives, providing expertise and ensuring deliverables
are provided on time, to budget, and in alignment with company, departmental or functional requirements.
* Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as
quality of other data management deliverables
* Champions and adopts technology improvements and tools for use in clinical data management processes.
* Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
* Performs other duties as assigned.
**Ce que vous ferez :** * Participe aux activités de supervision des fournisseurs au niveau des études. Peut représenter la fonction de gestion des données au sein de la sous-équipe clinique, garantissant l'harmonisation des attentes entre l'ORC et client pour tous les livrables liés aux données, notamment en ce qui concerne les points de décision clés et les soumissions réglementaires.
* Sert de premier point de contact pour les partenaires de l'ORC lorsqu'une collaboration est nécessaire pour garantir le respect des jalons et des livrables établis avec le plus haut niveau de qualité.
* Collabore avec les parties prenantes et les partenaires de l'ORC concernés pour atténuer et résoudre les risques.
* Pour les études dont les activités de gestion des données sont menées au sein de client, dirige et gère la mise en place de la collecte des données d'essais cliniques, la revue des données et le verrouillage de la base de données :
(a) Collabore avec d'autres fonctions pour finaliser la mise en place de l'EDC et d'autres outils de collecte de données d'étude tels que l'IRT, l'ePRO et l'eCOA.
(b) Diriger la création et la maintenance des éléments du plan de nettoyage des données d'étude, y compris les vérifications d'édition (plan de validation des données), les vérifications de révision des listes, les spécifications d'intégration des données, les spécifications de transfert de données, les plans de rapprochement des données externes, les directives de codage, les directives de rapprochement SAE et les plans de verrouillage des bases de données.(c) Diriger l'examen des données, y compris la gestion des requêtes, et diriger les activités nécessaires aux verrouillages intermédiaires et finaux des bases de données.
* Participer à la préparation de la fonction en vue de la soumission et peut représenter la fonction lors d'une inspection ou d'un audit formel.
* Assurer la préparation à l'archivage et à l'inspection de tous les documents du dossier principal d'essai (TMF) de gestion des données.
* Suivre les livrables de l'étude et évaluer les indicateurs de l'étude afin de réduire les risques liés aux principaux livrables et jalons de la gestion des données.
* Responsable de la planification et de la gestion des budgets et des échéanciers externes de gestion des données afin de garantir l'exactitude, de comprendre les tendances en matière de variance et de soutenir l'amélioration continue des prévisions.
* Peut préparer des indicateurs pour soutenir les indicateurs clés de performance (KPI) de la fonction.
* Représenter la fonction dans des initiatives et organisations professionnelles externes telles que SCDM, CDISC, DIA, etc. afin d'identifier les meilleures pratiques du secteur et d'accroître la visibilité de client.
* Contribuer aux initiatives fonctionnelles d'amélioration continue, en apportant son expertise et en veillant à ce que les livrables soient fournis dans les délais, dans le respect du budget et conformément aux exigences de l'entreprise, du service ou de la fonction.
* Travaille de manière transversale pour garantir la qualité des données de chaque base de données et leur livraison dans les délais, ainsi que la qualité des autres livrables de gestion des données.* Soutient et adopte les améliorations et les outils technologiques utilisés dans les processus de gestion des données cliniques.
* Assure la conformité avec ses propres programmes de formation, les exigences de l'entreprise et/ou les BPF.* Effectue d'autres tâches selon les besoins.
**You are:**
Educational Qualifications
* BS/BA required preferably in a health-related, life science area or technology-related fields.
Experience
* Preferred 4 plus years or experience in data management and/or drug development process with expertise in
the cross-functional interfaces with the data management function.
* Proven track record of strong project management skills and experience managing data management
activities for large drug development programs.
* NDA/CTD Experience preferred.
* Strong knowledge of data management best practices & technologies as applied to clinical trials.
* Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and
processes.
* Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data
management process
**Tu es:** Formation * Licence/Bachelor (BS/BA) requise, de préférence dans un domaine lié à la santé, aux sciences de la vie ou aux technologies. Expérience
* Expérience souhaitée de 4 ans ou plus en gestion de données et/ou en processus de développement de médicaments, avec une expertise des interfaces transversales avec la fonction de gestion des données.
* Excellentes compétences avérées en gestion de projet et expérience de la gestion des activités de gestion des données pour de grands programmes de développement de médicaments.
* Expérience en NDA/CTD souhaitée.
* Excellente connaissance des meilleures pratiques et technologies de gestion des données appliquées aux essais cliniques.
* Excellente compréhension des documents et processus des essais cliniques (protocoles, plans d'analyse statistique, CRF, rapports d'étude).
* Excellente connaissance des réglementations FDA et ICH, ainsi que des normes industrielles applicables à la saisie et à la gestion des données.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs
+ Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
+ Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Senior Clinical Data Manager
Posted 7 days ago
Job Viewed
Job Description
**What you will be doing:**
- Coordinates CDM process initiatives, including project management, process definition,
implementation, change management, and training plans.
- Provides regular communications to CDM staff on CDM Operation activities (e.g. process alerts,
training updates, changes, and initiative announcements).
- Supports the development and revision of CDM processes for both outsourced and in-house stud-
ies.
- May act as a point of contact and support for CDM staff on key process topics related to data
man- agement activities during study startup, conduct, and close out, and working in CDM systems.
- Collaborates with key stakeholders and CDM Operations to support CDM team on setup and man-
agement of EDC local lab activities.
- Supports the maintenance of the CDM Subject Matter Expert (SME) network for process topics, fa-
cilitating timely updates and discussions.
- Supports the maintenance and enhancements of departmental Sharepoint sites and trackers, as
needed.
- Assists in determining role assignment for the Learning Management System (LMS) and associated
learning plans.
- Supports CDM staff with Quality Assurance related activities such as inspection & audit
responses, in collaboration with the CDM Operations Compliance & Quality team.
-Coordonne les initiatives du processus CDM, notamment la gestion de projet, la définition des processus, la mise en œuvre, la gestion du changement et les plans de formation.
- Assure une communication régulière avec le personnel CDM sur les activités opérationnelles CDM (par exemple, alertes processus, mises à jour de formation, changements et annonces d'initiatives).
- Soutient le développement et la révision des processus CDM pour les études externalisées et internes.
- Peut servir de point de contact et de soutien au personnel CDM sur les aspects clés des processus liés aux activités de gestion des données pendant le démarrage, la conduite et la clôture des études, ainsi que sur l'utilisation des systèmes CDM.
- Collabore avec les principales parties prenantes et le service Opérations CDM pour soutenir l'équipe CDM dans la mise en place et la gestion des activités des laboratoires locaux d'EDC.
- Soutient la maintenance du réseau d'experts en la matière CDM pour les sujets de processus, facilitant ainsi les mises à jour et les discussions en temps opportun.
- Soutient la maintenance et l'amélioration des sites SharePoint et des outils de suivi du service, selon les besoins.
- Participer à la définition des rôles pour le système de gestion de l'apprentissage (LMS) et les plans de formation associés.
- Assister le personnel du CDM dans les activités liées à l'assurance qualité, telles que les inspections et les audits, en collaboration avec l'équipe Conformité et Qualité des opérations du CDM.
**You are:**
- Preferred 6 plus years or equivalent experience in data management and/or drug development pro-
cess with expertise in the cross-functional interfaces with the data management function.
- Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs,
study re- ports) and processes.
- Proven track record of strong project management skills and experience managing data management
activities for large drug development programs.
- Knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management;
clinical experience in one or more of the following therapeutic areas desired: cell therapy,
oncology, GI, Neu- roscience, PDT, Rare disease, Vaccines and/or vaccine.
- Preferred experience with FDA, EMA or other regulatory inspections of sponsor or CROs
- Ability to handle multiple projects simultaneously.
- Strong knowledge of data management best practices & technologies as applied to clinical
trials.
- Advanced knowledge of broad drug development process with expertise in the cross-functional
inter- faces with the data management function.
- Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture
and data management process.
- Au moins six ans d'expérience, ou équivalent, en gestion de données et/ou en processus de développement de médicaments, avec une expertise des interfaces transversales avec la fonction de gestion des données.
- Excellente compréhension des documents d'essais cliniques (protocoles, plans d'analyse statistique, CRF, rapports d'étude) et des processus.
- Excellentes compétences avérées en gestion de projet et expérience de la gestion des activités de gestion des données pour de grands programmes de développement de médicaments.
- Connaissance des BPC, des directives réglementaires et de l'ICH applicables à la gestion des données cliniques ;Expérience clinique souhaitée dans un ou plusieurs des domaines thérapeutiques suivants : thérapie cellulaire, oncologie, gastro-entérologie, neurosciences, PDT, maladies rares, vaccins.
- Expérience souhaitée avec la FDA, l'EMA ou d'autres inspections réglementaires de promoteurs ou de CRO.
- Capacité à gérer plusieurs projets simultanément.
- Excellente connaissance des meilleures pratiques et technologies de gestion des données appliquées aux essais cliniques.
- Connaissance approfondie du processus global de développement de médicaments, avec une expertise des interfaces transversales avec la fonction de gestion des données.
- Connaissance approfondie des réglementations FDA et ICH et des normes industrielles applicables au processus de saisie et de gestion des données.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs
+ Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
+ Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Clinical Data Manager II
Posted 7 days ago
Job Viewed
Job Description
**What you will be doing:**
Participate as the primary data management representative on multidisciplinary project teams and ensure effective communication exchange.
+ Responsible for communicating key clinical data management metrics (e.g., data entry status, query resolution and aging, etc.) and determining appropriate actions in conjunction with study team.
+ Responsible for the review, development and/or writing of clinical trial documents and manuals, including but not limited to Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans and eCRF Completion Guidelines.
+ Participate in User Acceptance Testing (UAT), as needed
+ Participate in Quality Control (QC), as needed.
+ Responsible for working with the assigned Clinical Database Programmer(s) to ensure the development of the Data Flow Chart(s), Data Transfer Specifications and Import Guidelines.
+ Assist with site and/or third party vendor training on CDM-related topics.
+ Responsible for providing data review training and guidance to Sr. Clinical Data Coordinators that are supporting their trial(s).
+ Perform data review and discrepancy resolution, as needed.
+ Responsible for archiving trial(s) and associated documentation upon trial(s) completion.
+ Ensure adherence to Good Clinical Practice and all applicable local and international regulations.
**You are:**
(8 -10 years' relevant lead experience)
+ Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN,
+ PA, RT) is preferred, but individuals with commensurate experience will be considered.
+ Experience with Electronic Data Capture (EDC) system(s) is required.
+ Experience with Oracle Inc.'s Inform EDC system is preferred.
+ Oncology and/or inflammatory therapeutic area experience is preferred.
+ Project management experience (within Data Management) is preferred.
Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is preferred.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs
+ Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
+ Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Clinical Data Manager (Canada)
Posted today
Job Viewed
Job Description
Job Description: The Clinical Data Manager I, will participate in various clinical data management activities required to ensure that data captured in a few clinical trials undertaken, or managed by Indero, are collected, managed and reported clearly, accurately and securely. In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Indero standard operating procedures (SOPs) while respecting Indero’s commitment to sponsor’s requirements and timeline RESPONSIBILITIESProvides general data management support to the project team, sponsor and external vendors, as needed.Is responsible for the development of electronic case report form (eCRF) specifications (including data capture screens and edit check specifications) needed to build a study-specific clinical database/electronic data capture (EDC) system.Is responsible for the programming and ongoing maintenance of the clinical database.Is responsible for the validation and testing of the clinical database (e.g. User Acceptance Testing).Is responsible for the development of eCRF completion guidelines and other training material required to train site users and monitors.Conducts training for site users/monitors on the clinical database.Develops data transfer agreements and specifications with vendors providing external data (e.g. laboratory results).Conducts reconciliation between external data and data in the EDC system to ensure consistency, including reconciliation with sponsor safety databases for adverse events/serious adverse events data (if needed).Provides support to study team in the development of external systems capturing clinical data, e.g. ePRO or IWRS, and ensuring that any data transfer requirements between these systems and EDC are documented and tested appropriately.Is responsible for the development of the data management plan (DMP), and other clinical data management related documentation. Is responsible for ongoing data review/cleaning during study conduct and also during preparation for database lock/close.Codes medical terms in the clinical database, as required.Generates data listings and reports needed for data review by the project manager (or other study team members) in preparation for database close/lock.Monitors study status (e.g. enrollment, CRFs monitored/approved, etc.) on an ongoing basis and provides data status reports to the project team, as needed.Ensures that data management documentation is complete and up-to-date in the trial master file (TMF).Activates/de-activates new users in the clinical database in response to requests from the project manager and maintains records of such requests.Responds to users requiring assistance with the EDC system.Is responsible for archiving of the clinical database and related documents.Participates in the definition, writing and updating of data management SOPsMentors and trains a Clinical Data Coordinator.For any studies where any of the above activities have been outsourced to an external service provider: -Oversees/manages the vendor to ensure that timelines and deliverables meet with sponsor and protocol requirements -Ensures that their work is done in accordance with effective work orders and Indero SOPs (if applicable).Our company: The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work scheduleComplete benefitsOffices near public transportation (Sherbrooke metro station or Saint-Laurent metro station)Possibility of working from home in accordance with company policies and public health directivesOngoing learning and development About Indero A Global Clinical Leader In Dermatology! Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Canada. Description - Fr: Le Gestionnaire de Données Cliniques I participera à diverses activités de gestion des données cliniques nécessaires pour s’assurer que les données recueillies dans quelques essais cliniques réalisés ou gérés par Indero sont collectées, gérées et rapportées de manière claire, précise et sécurisée. De plus, ce poste doit effectuer toutes ces activités conformément aux exigences réglementaires applicables, aux lignes directrices de l’industrie et aux procédures opérationnelles normalisées (SOP) d’Indero, tout en respectant l’engagement d’Indero envers les exigences et les échéances des sponsors. Fournir un soutien général en gestion des données à l’équipe projet, au sponsor et aux fournisseurs externes, selon les besoins.Être responsable du développement des spécifications des formulaires électroniques de rapport de cas (eCRF) (y compris les écrans de saisie des données et les spécifications des vérifications de cohérence) nécessaires à la création d’une base de données clinique/un système de capture électronique des données (EDC) spécifique à l’étude.Être responsable de la programmation et de la maintenance continue de la base de données clinique.Être responsable de la validation et des tests de la base de données clinique (par exemple, tests d’acceptation par les utilisateurs).Être responsable de l’élaboration des guides de remplissage des eCRF et d’autres documents de formation nécessaires pour former les utilisateurs des sites et les moniteurs.Dispenser la formation aux utilisateurs des sites et aux moniteurs sur la base de données clinique.Élaborer des accords et des spécifications de transfert de données avec les fournisseurs de données externes (par exemple, résultats de laboratoire).Effectuer la réconciliation entre les données externes et les données de l’EDC afin de garantir leur cohérence, y compris la réconciliation avec les bases de données de sécurité des sponsors pour les événements indésirables/événements indésirables graves (si nécessaire).Apporter un soutien à l’équipe d’étude dans le développement des systèmes externes de capture des données cliniques, par exemple ePRO ou IWRS, et s’assurer que les exigences en matière de transfert de données entre ces systèmes et l’EDC sont documentées et testées de manière appropriée.Être responsable de l’élaboration du plan de gestion des données (DMP) et d’autres documents relatifs à la gestion des données cliniques.Être responsable de la revue et du nettoyage continus des données pendant la conduite de l’étude ainsi que lors de la préparation de la fermeture/du verrouillage de la base de données.Coder les termes médicaux dans la base de données clinique, selon les besoins.Générer les listings de données et les rapports nécessaires à la revue des données par le chef de projet (ou d’autres membres de l’équipe d’étude) en préparation de la fermeture/du verrouillage de la base de données.Surveiller en continu l’état de l’étude (par exemple, inclusion des participants, CRF monitorés/approuvés, etc.) et fournir des rapports d’avancement des données à l’équipe projet, selon les besoins.Veiller à ce que la documentation relative à la gestion des données soit complète et à jour dans le dossier maître de l’étude (TMF).Activer/désactiver les nouveaux utilisateurs dans la base de données clinique suite aux demandes du chef de projet et conserver les enregistrements de ces demandes.Répondre aux utilisateurs nécessitant une assistance avec le système EDC.Être responsable de l’archivage de la base de données clinique et des documents associés.Participer à la définition, la rédaction et la mise à jour des SOP de gestion des données.Encadrer et former un Coordinateur des Données Cliniques.Pour toute étude dont certaines des activités ci-dessus sont sous-traitées à un prestataire externe : -Superviser/gérer le fournisseur afin de garantir que les échéances et livrables respectent les exigences du sponsor et du protocole. -S’assurer que leur travail est réalisé conformément aux bons de commande en vigueur et aux SOP d’Indero (le cas échéant).Profil recherché: Baccalauréat (B.Sc.) dans un domaine d’études connexe ;Ou maîtrise (M.Sc.) dans un domaine d’études connexe (un atout) ;Minimum de 2 ans d’expérience en gestion des données cliniques dans le domaine de la recherche clinique, au sein de l’industrie biotechnologique, pharmaceutique ou dans une organisation de recherche sous contrat (CRO) ;Bonne compréhension du processus de développement des médicaments et des réglementations applicables, y compris les Bonnes Pratiques Cliniques (BPC) et les lignes directrices de l’ICH ;Expérience approfondie avec les systèmes EDC et/ou les structures de bases de données, incluant des compétences démontrées en programmation de bases de données ;Bonne compréhension des normes CDISC SDTM/CDASH ;Excellente capacité d’organisation et souci du détail, avec des compétences efficaces en planification de projet et en gestion du temps ;Solides compétences en communication orale et écrite en anglais ;Excellentes aptitudes en résolution de problèmes ;Capacité à travailler dans un environnement dynamique, avec une agilité démontrée pour gérer et prioriser plusieurs demandes concurrentes ;Connaissance des dictionnaires MedDRA et WHODrug.Notre entreprise: Chez Indero, vous travaillerez avec des collaborateurs compétents et dynamiques. Nos valeurs sont la collaboration, l’innovation, la fiabilité et la réactivité. Nous offrons un environnement de travail stimulant et des possibilités d’avancement intéressantes. Dans ce poste, vous bénéficierez des conditions suivantes :Flexibilité sur l’horaireGamme d’avantages sociauxBureau à proximité du transport en commun (métro Saint-Laurent ou métro Sherbrooke)Possibilité de travail à la maison en fonction des politiques de l’entreprise et des directives de la santé publiqueFormation et développement continu À propos d’Indero Un leader mondial de la recherche clinique en dermatologie! Anciennement connu sous le nom d’Innovaderm, Indero est un expert de renommée mondiale et un leader en recherche clinique en dermatologie. Forts de plus de vingt ans d’expérience, nous couvrons un large éventail d’indications, de populations de patients, de voies d’administration et de classes de médicaments, avec une présence à l’échelle mondiale. Indero est une CRO spécialisée en dermatologie et en rhumatologie, avec plus de 25 ans d’expérience en recherche clinique et en gestion d’essais. Notre approche clé en main – qui comprend la conception du protocole, le recrutement des patients, le suivi des essais et les analyses biométriques – offre aux entreprises de biotechnologie et aux laboratoires pharmaceutiques les bases scientifiques rigoureuses et l’expertise ciblée dont ils ont besoin pour mener leurs études à terme de manière efficace et efficiente. Grâce à une présence en Amérique du Nord, en Europe, en Asie-Pacifique et en Amérique latine, à des relations étendues et en constante croissance avec les investigateurs et les patients, ainsi qu’à une clinique de recherche dédiée par laquelle nous concevons et menons nos propres études, Indero est le partenaire CRO idéal pour répondre aux besoins cliniques à l’échelle mondiale. Indero s’engage à offrir un traitement équitable et des chances égales à toutes et à tous. À ce titre, Indero fournira, sur demande, des mesures d’adaptation tout au long du processus de recrutement et de sélection pour les personnes en situation de handicap. Veuillez noter : Indero n’accepte que les candidatures de personnes autorisées à travailler légalement au Canada. Brand name: Indero Requirements:B.Sc. in a related field of study;Or M. Sc. in a related field of study is an asset;At least 2 years of clinical data management experience in clinical research in the biotechnology, pharmaceutical, or contractual research organization (CRO) industry;Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines;Extensive experience working with EDC systems, and/or database structures, including demonstrated skills in database programming;Good understanding of CDISC SDTM/CDASH standards;Highly organized and detail-oriented with effective project planning and time management skills.Strong verbal and written communication skills in English;Excellent problem solving abilities;Ability to work in a fast-paced environment with demonstrated agility to juggle and prioritize multiple competing demands;Knowledge of MedDRA and WHODrug dictionaries
Product Data Manager - Ecommerce
Posted today
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Job Description
FortNine is a rapidly growing motorcycle and powersports e-commerce company. Join a team of multidisciplinary experts passionate about making an impact on the industry and redefining how people shop in Canada!
At FortNine, the Product Data Manager is at the heart of our e-commerce. You’re an online pro, comfortable navigating and obtaining data all over the internet. As we continue growing, so do the number of items we have available; you’d play a pivotal role in setting up new products, maintaining product data to be used for our ecommerce platform, managing listings, optimizing product visibility, and analyzing data that will contribute to continuing our market dominance.
We’re looking for someone that is technologically comfortable, experienced in navigating multiple programs with speed and precision, and who has a measure of curiosity in learning more about the powersports space. No existing powersports knowledge required (although welcomed)! We’ll provide you with all the tools and resources necessary to your success, and in becoming a fully-fledged FortNiner! If you enjoy working in a tech-focused e-commerce, with an inclusive community that has an emphasis on fostering and developing its people, you’ll fit right in. Get in touch! We’d love to meet.
Please note: This is an entry level role ! We're hoping to invest in and develop our staff by providing comprehensive training, a great learning environment, and exposing you to the greater world of e-commerce! Any and all tech-savvy candidates are invited to apply.
Major Responsibilities:
- Selecting new products to be added to our website.
- Preparing data feeds for new products being added to our website using information collected from various sources, while maintaining accurate and up-to-date product information for current products.
- Organizing and enhancing product data to assist customers in understanding the difference between various products.
- Resolving catalog/data issues, including missing or outdated information, erroneous images, among others.
Job Requirements:
- Understanding of e-commerce shopping. You have your favorite online stores, and you know why you like them.
- Proficiency in spreadsheets (Microsoft Excel) required. You know what formulas and macros are, and possess a basic understanding of best practices!
- Very strong computer and internet browser/data manipulation skills (ctrl-c and ctrl-v are in your muscle memory. Googling is an action verb.)
- Must be based locally (Montreal, QC).
- English: Excellent written and verbal skills.
- Bonus: Knowledge of SQL or any type of scripting, basic familiarity with CSS and HTML.
- Bonus: Knowledge of the automotive, marine, cycling and/or powersports industry
What we offer:
- Starting Salary for this position is between $45 000 - $50 000 a year.
- Paid personal days.
- Health Insurance including medical, dental, vision and life.
- Unlimited free healthy snacks and drinks on site.
- Quiet, clean and newly built office environment.
- Located within a 5-minute walk from Du College station (orange line) and offering free parking.
- Ergonomic workstations and the best tools made available to you.
- Hard working, respectful and friendly coworkers.
- Free parking or easy access via public transit.
- A strong culture that encourages collective accomplishments and enables individual progression. We have great parties.
--- Version Française ---
FortNine est une entreprise de commerce électronique de motos et de sports motorisés en pleine croissance. Joignez-vous à une équipe d'experts multidisciplinaires passionnés par l'idée d'avoir un impact sur l'industrie et de redéfinir la façon dont les gens font leurs achats au Canada.
Chez FortNine, le gestionnaire de produits est au cœur de notre commerce électronique. Vous êtes un pro de l'Internet, à l'aise pour naviguer et obtenir des données en ligne. Vous jouerez un rôle central dans la mise en place de nouveaux produits, dans le maintien des données de produits à utiliser sur notre plateforme de commerce électronique, dans la gestion des annonces, dans l'optimisation de la visibilité des produits, et dans l'analyse des données qui contribueront à maintenir notre position dominante sur le marché.
Nous recherchons une personne à l'aise avec la technologie, expérimentée dans la navigation de plusieurs programmes avec rapidité et précision, et qui a une certaine curiosité pour en apprendre davantage sur l'espace des sports motorisés. Aucune connaissance préalable des sports motorisés n'est requise ! Nous vous fournirons tous les outils et les ressources nécessaires à votre succès, et à devenir un FortNiner à part entière ! Si vous aimez travailler dans un e-commerce axé sur la technologie, avec une communauté inclusive qui met l'accent sur l'encouragement et le développement de son personnel, vous vous intégrerez parfaitement. Contactez-nous! Nous serions ravis de vous rencontrer.
Responsabilités Principales :
- Sélection de nouveaux produits à ajouter sur notre site web.
- Préparer les flux de données pour les nouveaux produits ajoutés à notre site Web en utilisant les informations recueillies auprès de diverses sources, tout en maintenant des informations précises et à jour pour les produits actuels.
- Organiser et améliorer les données sur les produits pour aider les clients à comprendre la différence entre les différents produits.
- Résoudre les problèmes de catalogue/données, notamment les informations manquantes ou périmées, les images erronées, entre autres.
Exigences du poste :
- Compréhension des achats en ligne. Vous avez vos boutiques en ligne préférées, et vous savez pourquoi vous les aimez.
- Compétences informatiques supérieures avec une certaine maîtrise des feuilles de calcul (Excel) requises.
- Très bonnes compétences en matière de navigation Internet et de manipulation des données (ctrl-c et ctrl-v sont dans votre mémoire musculaire).
- Anglais : Excellentes compétences écrites et verbales.
- Doit être basé localement (Montréal, QC).
- Bonus : Connaissance de SQL ou de tout type de script, connaissance de base de CSS et HTML.
- Bonus : Connaissance de l'industrie automobile, marine, cycliste, et/ou des sports motorisés.
Ce que nous offrons :
- Le salaire de départ pour ce poste se situe entre 45 000 et 50 000 dollars par année.
- Journées personnelles payées
- Assurance santé comprenant une assurance médicale, dentaire, vision et vie
- Des collations et des boissons saines
- Environnement de bureau calme, propre et récemment construit
- Situé à 5 minutes à pied de la station Du College (ligne orange) et offrant un parking gratuit
- Des postes de travail ergonomiques et les meilleurs outils mis à votre disposition.
- Collègues travailleurs, respectueux et amicaux.
- Stationnement gratuit ou accès facile par les transports en commun
- Une culture forte qui encourage les réalisations collectives et permet la progression individuelle. Nos fêtes sont superbes.
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Lead Clinical Data Manager
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Senior Lead Clinical Data Manager – Top CRO – Fully Remote – Permanent
Summary
My client is a global CRO who have revolutionized the field of data science and are rapidly expanding their data management team for clinical trial data. This is an exciting opportunity to join a CRO working directly with pharmaceutical sponsors, with a diverse range of career progression avenues and specialties to explore. This is a fantastic leadership position in CDM in a thriving industry and is not one to miss.
What will you be doing?
- As part of the data management team, you will be involved in the strategic acquisition of data from clinical trials and the designing and validation of databases.
- Using your lead experience, you will provide comprehensive data management expertise to the clinical data management team to provide high quality data management products that meet customers’ needs in a variety of therapeutic areas.
- Using your experience in industry, you will also direct the team in areas of project planning, execution and close-out, financial management, communications, and milestone deliverables.
- You will serve as the primary point of contact between the vendor and the study team for DM deliverables in this client facing role.
What do you need?
- Ideally 7+ years in CDM with at least 3 of those in an independent lead capacity.
- CRO background preferred
- Ability to present in weekly meetings, collaborating with a global team.Demonstrated extensive DM skills and thorough knowledge of DM processes
- Bachelor’s degree or equivalent in a biological or mathematical discipline preferred.
- Excellent project management and organizational skills.
What do you get in return?
- $105,000 - $150,000 CAD per year + a comprehensive benefits package including 401k contribution, Bonus, Medical, Dental and Vision Insurance.
- Exciting career progression opportunities with multiple areas to specialize into
- Excellent management support in a large, well-established CRO.
- Flexibility on schedule.A genuine focus on work-life balance.
What to do next?
If this opportunity is of interest, please apply now with your Resume to avoid missing out.
Principal Clinical Data Manager
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Principal Clinical Data Manager | Global CRO | Full Time | Remote North America
Our client is a well-established mid-sized CRO based in the Toronto Area and known for providing top-notch clinical solutions to a range of small and mid-sized Biotech companies.
They are currently seeking a Principal Clinical Data Manager to join their team in Bridgewater NJ, or remotely within North America. This is a lead role requiring the candidate to have at least 8 years of experience in Clinical Data Management within a CRO or Pharma setting, as well as 5 years of independent Lead experience.
Key Responsibilities:
- Manage data processing tasks and timelines for clinical trials
- Oversee data quality control, ensuring compliance with SOPs and sponsor guidelines
- Lead data management projects, coordinate activities, and develop database validation checks
- Design case report forms (CRFs) and handle quality control
- Train and guide junior staff and data entry teams
Requirements:
- Bachelor’s degree in a scientific field and 5+ years of independent lead experience, 8-10+ years total in Data Management.
- Familiarity with clinical trial regulations and data management processes
- Strong leadership and interpersonal skills
Apply now to avoid missing out on this opportunity!