Gestionnaire de données cliniques – Clinical Data Manager

This is a fully remote position, open to applicants in Canada.

📋 Description

• Lead and oversee clinical studies, ensuring that data is collected, managed, and reported in a clear, accurate, and secure manner.

• Serve as the data management liaison for project teams, sponsors, and external vendors.

• Manage up to three studies with support from management.

• Participate in sponsor meetings and address data management inquiries.

• Track timelines, scope, budgets, enrollment, and the status of study data.

• Create eCRF specifications, data capture screens, and edit checks for clinical databases and EDC systems.

• Program, maintain, validate, and test clinical databases, including User Acceptance Testing (UAT).

• Develop guidelines for eCRF completion and materials for training.

• Train site users and monitors on the use of clinical databases.

• Create data transfer agreements and specifications with external data vendors.

• Reconcile external data, EDC data, and sponsor safety databases as necessary.

• Support the development of ePRO and IWRS systems and document/test data transfers.

• Create data management plans and associated documentation.

• Conduct ongoing data review and cleaning through to database lock/close.

• Code medical terms as required.

• Generate data listings and reports for data review purposes.

• Ensure complete and up-to-date data management documentation is maintained in the TMF.

• Respond to user assistance requests related to EDC.

• Archive clinical databases and related documentation.

• Support data management work instructions.

• Mentor and provide training to a Clinical Data Coordinator.

• Oversee outsourced vendors to ensure compliance with timelines and deliverables.

⛳️ Requirements

• Bachelor's degree in science or a related field.

• 3 to 5 years of experience in clinical data management, or at least 1 year in a lead clinical data manager role, in biotechnology, pharmaceuticals, or CRO clinical research.

• Familiarity with the drug development process and relevant regulations, including Good Clinical Practices and ICH Guidelines.

• Extensive experience with EDC systems and/or database structures.

• Proven database programming skills are advantageous.

• Knowledge of CDISC SDTM/CDASH standards.

• Strong skills in project planning and time management.

• Excellent verbal and written communication skills in English; proficiency in French is a plus.

• Exceptional problem-solving skills.

• Knowledge of SAS or similar tools is beneficial.

• Proficient in Microsoft Excel.

• Ability to organize and prioritize multiple competing tasks in a fast-paced environment.

• Familiarity with MedDRA and WHODrug dictionaries.

• Good understanding of Good Clinical Practices and relevant Health Canada and FDA regulations/guidelines.

• Legally authorized to work in Canada.

🏝️ Benefits

• Flexible work schedule.

• Home-based position.

• Opportunities for ongoing learning and development.

• Attractive opportunities for advancement.

• Comprehensive benefits package (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transit discounts, social activities).

• Permanent full-time position.