Spineart is currently recruiting for the headquarter a
SENIOR CLINICAL DATA MANAGER
The Senior Clinical Data Manager will oversee all aspects of the clinical trial data management of Spineart clinical studies conducted in-house and outsourced.
Missions
- Lead and oversee clinical study Data Management activities conducted in-house and outsourced.
- Oversee EDC vendors, EDC build and performance (e.g. User Acceptance Testing, eCRF edit checks, issue management, EDC supplier management)
- Design CRFs compatible with EDC and paper studies, with the Project Manager and team and ensure data consistency across studies.
- Write or review data management documentation.
- Identify and troubleshoot data management issues and obstacles for studies
- Liaise closely with study statistician and conduct any necessary QC on data outputs from statistician.
- Review protocols, Statistical Analysis Plans, CSRs, and other documents as required.
- Development and maintenance of data management SOPs and Work Instructions
Profile:
- 5+ years of experience in clinical data management /programming in the medical device /pharmaceutical industry.
- Expert in Excel and basics SAS programming skills
- Ability to work in English (daily working language), French would be an asset
- Bachelor’s degree or equivalent in a Life Sciences, Data Management, BioStatistics, or equivalent.
- Capacity to work with a team.
- Proactive and accountable work ethic and ability to multitask.
- Strong organization and detail oriented.