Clinical Data Manager
WhiteCap Search · Cambridge, MA · 1 mo ago
On-siteScienceContract
Key Responsibilities
- Develop and maintain data management plans (DMPs), edit check specifications, and data validation plans
- Build and test eCRFs and database structures in collaboration with EDC vendors (Medidata Rave, Veeva, InForm, or similar)
- Review incoming clinical data for quality, completeness, and consistency; manage query generation and resolution
- Cover external data reconciliation (labs, ECG, IRT/RTSM, etc.)
- Support database lock activities, including UAT, SAE reconciliation, and final data extracts
- Partner with biostatistics and SAS programming teams on dataset specifications and delivery timelines
- Maintain data management documentation in support of audit and inspection readiness
Qualifications
- Bachelor's degree in life sciences, health informatics, or related field
- 3+ years of clinical data management experience in pharma, biotech, or CRO
- Hands-on experience with at least one major EDC system (Medidata Rave strongly preferred)
- Familiarity with CDISC standards (CDASH/SDTM) a plus
- Strong attention to detail and comfort working independently in a small-team environment
- Experience supporting database lock and clean file activities