Senior Manager, Clinical Data Management
New
United StatesFull-TimeManager
Salary not disclosed
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Job Details
- Experience
- 8+ years
- Required Skills
- People Management
Requirements
- Bachelor’s degree in Mathematics, Life Sciences, or a related field.
- 8+ years of clinical data management experience within the pharmaceutical, biotech, or clinical research industry.
- Strong knowledge of regulatory requirements, including 21 CFR Part 11 and ICH-GCP guidelines.
- Proven experience leading clinical studies and managing or mentoring data management teams.
- Deep understanding of clinical data management processes, standards, and end-to-end study lifecycle activities.
- Certified Clinical Data Manager (CCDM) certification strongly preferred.
- Experience in people management, team development, and cross-functional collaboration.
- Strong attention to detail and organizational skills.
Responsibilities
- Lead clinical data management activities across multiple studies from study start-up through database lock and archiving.
- Serve as the primary point of contact for study teams, CROs, and external data vendors.
- Oversee data quality review, validation processes, coding activities, reconciliation, and database closure.
- Review and approve key study documentation, including data management plans and specifications.
- Ensure inspection readiness by maintaining compliant documentation in eTMF.
- Manage data transfers and integration across systems.
- Collaborate with cross-functional teams to align timelines and resolve risks.
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