Senior Manager, Clinical Data Management

What You’ll Do

• Lead day-to-day clinical data management operations across MBX programs.
• Oversee EDC and eDiary/eCOA design/development and database modifications, including specifications review/approval.
• Oversee and perform UAT, validation activities, and documentation for compliant, high-quality databases.
• Develop, maintain, and update Data Management Plans (DMPs), CRF Completion Guidelines (CCGs), and related DM documentation.
• Lead data review meetings and deliver data listings to clinical and medical teams.
• Perform proactive data surveillance and critical data reviews/reconciliations for completeness, quality, and timely primary/key secondary endpoint data.
• Oversee CRO data management teams and external data vendors; manage Data Transfer Agreements and ensure timely (and quality) data transfers.
• Oversee integration/reconciliation of external data sources (IRT, eCOA/eDiary, labs, imaging, safety).
• Plan and execute database interim/final locks; manage timelines, risks, and on-time delivery to Biostatistics.
• Oversee final subject data profile format review/deliveries; ensure TMF data management documentation QC and inspection readiness.

• Master’s in Life/Health Sciences, Data Management, Computer Science, or related field (advanced degree preferred).
• 9+ years in Clinical Data Management (biotech/pharma/CRO), including Lead Data Manager on global Phase 2/3 studies.
• Hands‑on experience with Medidata Rave (or equivalent) EDC: design, database development, specifications review, UAT, modifications, lock.
• Experience with eCOA/eDiary systems, including design/specification review, UAT, modifications, and vendor management.
• Experience with multi‑source data (central lab, IRT, specialty labs, etc.).
• Strong knowledge of ICH‑GCP, regulatory requirements, inspection readiness, and TMF expectations.
• Proven ability to oversee vendors/CROs and manage DM deliverables across studies; strong cross‑functional communication and problem‑solving.