Our Clinical team manages studies to provide the safety, performance and clinical benefit data required for regulatory approval and renewal of a broad portfolio of spine surgery medical devices.
This team is currently looking for its new experienced Lead Clinical Data Manager.
• Responsible for all Clinical Data Management activities from the protocol development through to the database lock.
• Manage CROs and vendors assigned with data management and EDC services.
• Oversee EDC build and performance (e.g. User Acceptance Testing, eCRF edit checks, issue management, EDC supplier management)
• Ensure data reconciliation between clinical database and other databases (e.g. radiographic image database).
• Work in close collaboration with the Clinical Project Managers, Statisticians and all relevant stakeholders throughout the studies.
• Effectively designs CRF with the Project Manager and team.
• Ability to articulate the CRF questions to ease data entry by sites and to ensure
• Write or review data management documentation.
• Identify and troubleshoot data management issues and obstacles for studies
• May train and mentor other junior Clinical Data Managers.
• Review protocols, Statistical Analysis Plans, CSRs, and other documents as required.
• Development and maintenance of data management SOPs and Work Instructions
The Lead Clinical Data Manager role is responsible for end to end clinical data management of small and medium sized post market clinical trials on spine surgery medical devices. This role will include oversight of outsourced data management and EDC activities.
• Bachelor’s degree or equivalent in a Life Sciences or health related discipline
• At least 5 years’ experience in clinical data management leading clinical trials
• Experience the medical device industry is an asset
• Good working knowledge of clinical practice and medical terminology.
• knowledge of database structures and available tools to manage, extract, and report data.
• Understanding of ISO 14155 and regulatory environment as it pertains to data management
• Excellent organizational, project management and problem solving skills
• Strong team collaborator and ability to lead as needed.
• Ability to coordinate the work of others
• Fluent in English (spoken and written) and proficiency in French preferred
- Additional statistical programming skills are an asset, to program simple data listings and summary tables for data reviews and status reports, and to perform data quality control of programs and QC of statistical tables, listings, and figures.
If you match with our requirements and that you are interested in working in this challenging career opportunity, in a dynamic growing and technology driven environment, we look forward to receiving your complete application, incl. a motivation letter.