Clinical Data Manager

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

📋 Description

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

• Ensure that clinical data management activities comply with regulatory standards, industry guidelines, SOPs, sponsor requirements, and timelines.

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

• Manage up to three studies, depending on their complexity.

• Participate in sponsor meetings and address any data-management-related inquiries.

• Track timelines and scope of work to ensure projects are completed on time and within budget.

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

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

• Develop eCRF completion guidelines and training materials; provide training to site users and monitors.

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

• Reconcile external data with EDC data and sponsor safety databases as required.

• Assist in the development of external clinical data systems such as ePRO and IWRS, while documenting and testing data-transfer needs.

• Create the data management plan and associated documentation.

• Conduct continuous data review and cleaning throughout the database lock/close process.

• Code medical terminology within the clinical database.

• Produce data listings and reports for data review and database closure/lock.

• Monitor study progress and provide data status reports to project teams.

• Maintain comprehensive and current data management documentation in the TMF.

• Assist EDC system users who require support.

• Archive clinical databases and related documents.

• Aid in writing and updating data management Work Instructions.

• Mentor and train a Clinical Data Coordinator.

• Supervise external service providers to ensure compliance with timelines, deliverables, work orders, sponsor requirements, protocol requirements, and SOPs.

• Undertake other assigned responsibilities as qualified and adequately trained.

⛳️ Requirements

• Bachelor’s degree in a related field of study.

• 3 to 5 years of experience in clinical data management, or at least 1 year as a lead clinical data manager in the biotechnology, pharmaceutical, or CRO industry.

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

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

• Proven skills in database programming are advantageous.

• Strong understanding of CDISC SDTM/CDASH standards.

• Highly organized and detail-oriented, with effective project planning and time management skills.

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

• Strong problem-solving capabilities.

• Knowledge of SAS or similar software is beneficial.

• Proficient in MS Excel.

• Ability to thrive in a fast-paced environment and manage multiple competing priorities.

• Familiarity with MedDRA and WHODrug dictionaries.

• Good understanding of good clinical practices and relevant Health Canada and FDA regulations/guidelines.

• Must have legal authorization to work in Canada.

🏝️ Benefits

• Flexible work schedule.

• Remote work position.

• Continuous learning and development opportunities.

• Attractive career advancement prospects.

• Accommodations available throughout the recruitment and selection process for applicants with disabilities, upon request.