Senior Clinical Data Manager
Waltham, MA | Contract
Duration: 6-12 Months (possibility to convert)
Location: Waltham, Massachusetts
Top 3 Technical Skills:
- Vendor oversight experience
- Late phase experience (phase II and phase III Studies)
- Database lock experience
- Senior level vendor oversight experience
The Senior. Clinical Data Manager is responsible for managing all aspects of the global clinical study data management process from start-up to database lock and regulatory submission support. The Senior Clinical Data Manager will ensure clean and valid clinical study data for delivery to biostatistics. This position coordinates activities with the Contract Research Organization (CRO), other external vendors, database programming and trial operations to define and implement data management requirements.
- Actively participates in multiple cross-functional teams to ensure the effective delivery of assigned project milestones.
- Work closely with CROs during the design and development of Electronic Case Report Forms (eCRFs), CRF Completion Guidelines (CCGs), Edit Checks and Data Management Plans (DMPs)
- Oversees the deliverables of external data management vendors for quality, completeness and adherence to timelines
- Manage and track database lock timelines and ensure CDM project milestones are met in coordination with the project team.
- ]Support study-level audit and inspection readiness activities, as needed.
- Bachelor's degree in science/health- related area with 6+ years of experience as a Data Manager
- Working knowledge of industry regulations and standards
- Experience with Medidata RAVE