Ecocareers · 3 months ago
Sr. Clinical Data Manager
San Diego, CA
Full-time
Onsite
Senior Level
5+ years expEcocareers is a confidential company seeking a Sr. Clinical Data Manager. The role involves overseeing data management activities across clinical trials, ensuring data consistency, and supporting cross-functional activities related to biometrics and regulatory submissions.
Staffing & Recruiting
Responsibilities
Oversee data management activities to maintain consistency across trials including Case Report Form (CRF) design, Data Management Plans, CRF annotation, edit check programs, data entry and query status tracking, and database closure
Oversee database design, migration or expansion, including UAT and documentation
Proactively identify risks and execute risk mitigation strategies; Maintain timely communication with both upper management and cross-functional teams
Oversee the tracking of important study metrics on data entry, source verification, and query status, and presenting these metrics to a cross-functional team as required
Perform reviews of clinical trial data to ensure all captured data follows the rules outlined by the protocol and Data Management Plan
Support cross-functional activities related to biometrics, regulatory submissions and clinical program development as needed
Qualification
Required
Minimum of 5+ years of CDM experience in biotech or pharmaceutical industry; or equivalent education and experience
Ability to manage multiple programs, and multiple studies within a program
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Experience supporting Phase 3 studies, BLA submission and FDA/MHRA audits
Proficient in CDMS (ex: Medidata, Clintrak), Microsoft Office Suite (ex: Word, Excel, PowerPoint)
Understand the principles of clinical research (ex: ICH GCP, CDISC and GCDMP)
Preferred
BS degree in a life science or related field
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase