Position Summary
The Senior Clinical Data Manager is an expert in clinical data management with demonstrated capability in building and maintaining clinical trial databases. Contributes to process improvements within the Biometrics department and mentors/trains junior staff.
Essential Functions
- Create/review study-specific electronic or paper Case Report Forms (CRFs) using protocol and departmental standards.
- Configure, migrate, and test EDC databases; serve as study database manager including compilation of edit checks.
- Develop database requirements for EDC vendors; obtain vendor deliverables.
- Create/review data management and database documentation (Data Management Plan, CRF Completion Guidelines, Coding Guidelines, Annotated CRFs, Edit Check Specifications).
- Attend study team meetings; produce status reports and requested metrics.
- Perform data review and query generation/closure.
- Code verbatim terms (e.g., adverse events, concomitant medications) with medical scientists; incorporate coding files into the clinical database.
- Participate in process development/revisions.
- Train internal colleagues; train Investigators and/or Study Coordinators on CRFs, EDC system, and completion guidelines.
- Provide data management expertise/support and analytical insight for data management strategies.
- Provide guidance/mentoring to junior staff when necessary.
- Perform other special projects as requested.
Education & Experience
- Bachelor’s degree in a science-related field with 5+ years experience; or High school diploma with 9+ years relevant experience.
- 5+ years clinical data management experience required.
- Experience with EDC clinical databases required.
- Veeva Vault CDMS and TrialMaster preferred.
- MedDRA and WHO Drug coding preferred.
Knowledge, Skills, Abilities
- Working knowledge of clinical research, GCP, and regulatory requirements.
- Knowledge of CDISC/STDM standards.
- Excellent verbal/written communication; organizational and interpersonal skills.
Working Environment
- Onsite or remote based on location; Monday–Friday standard business hours (flexibility with manager approval).
- Mobility to use standard office equipment; lift/carry up to 20 lbs.
Application Instructions
- Application window anticipated to close 60 days from posting (or sooner if filled/closed).