Senior Clinical Data Manager
USFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 5+ years
- Required Skills
- GCP
Requirements
- Bachelor’s degree
- 5+ years of experience in clinical data management
- Experience in sponsor-side clinical trials
- Expertise in eCRF design, database build, edit checks, and UAT execution
- Knowledge of EDC/CDMS systems and eTMF management
- Understanding of 21 CFR Part 11, GCP, ICH E6(R3), ISO 14155, and 21 CFR Part 812
- Experience managing external vendors and CROs
Responsibilities
- Lead the design, build, and configuration of clinical study databases (EDC, CTMS, eTMF).
- Execute and document user acceptance testing for clinical databases.
- Develop and maintain data management plans and CRF completion guidelines.
- Oversee ongoing data review, query management, and data cleaning processes.
- Manage user access, role-based permissions, and audit trails.
- Coordinate database lock activities and submission readiness.
- Manage vendor and CRO relationships including deliverables and budgets.
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