Overcoming the limitations of conventional CRT through Wireless, LV Endocardial Pacing
Senior Clinical Data Manager
Location
United Kingdom
Posted
31 days ago
Salary
$115.6K - $156.4K / year
Seniority
Senior
Job Description
Senior Clinical Data Manager
EBR Systems, Inc.
• The Clinical Data Manager (or Senior Clinical Data Manager, based on experience) will lead database development and management efforts — encompassing EDC, eTMF, and CTMS systems. • This role requires deep expertise in clinical data management and system build, as well as proficiency in data visualization. • The ideal candidate will have demonstrated hands-on experience designing, building, implementing, and maintaining clinical data systems from the ground up, ensuring high-quality data outputs that support regulatory submissions and cross-functional decision-making. • This individual will serve as the functional owner of all clinical data systems and infrastructure and will be expected to assess, revise, and strengthen existing SOPs and data management processes to meet regulatory and operational standards. • Lead development, implementation, and ongoing management of eTMF and CTMS systems in collaboration with Clinical Affairs, Regulatory Affairs, and IT stakeholders.
Job Requirements
- Bachelor’s degree in life sciences, biostatistics, computer sciences, or a related field is required.
- Advanced degree in life sciences, biostatistics, computer sciences or a related field is a plus.
- Minimum of 5+ years (Manager) or 7+ years (Senior Manager) in clinical data management.
- Experience supporting IDE or PMA submissions, specifically the data management and data package components, is strongly preferred.
- Hands-on EDC programming and database build experience; proficiency in Imedidata, Medidata Rave, or Zelta (Navitas) is required.
- Experience with additional platforms such as Veeva Vault or REDCap is a plus.
- Experience with cardiac rhythm management (CRM) systems or comparable Class III cardiovascular medical device clinical trials is required.
- Demonstrated competency in hands-on EDC system build and configuration, eTMF platform administration, and CTMS management is strongly preferred.
- Class III medical device experience, specifically in cardiovascular / cardiac rhythm management (CRM) or a comparable Class III CV device program, is required.
Benefits
- Medical, dental, and vision insurance provided at no cost for employee-only coverage
- 401(k) matching plan
- Paid Time Off – starting at 3 weeks per year
- Competitive salary with opportunities for career growth
- Employee stock options
- Life & AD&D and long-term disability insurance
- Education assistance
- Voluntary commuter benefits and pet insurance
- Meaningful work and much more!
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