The Senior Clinical Data Manager is an individual contributor performing complex data management tasks independently. The Senior Clinical Data Manager plays a key role
Reporting Relationship: Senior Director, Data Management
- Develops, or plans and oversees development of, edit check specifications, CRF Completion Guidelines or Data Entry Guidelines, Data Management Plan, Data Review Guidelines, SAE Reconciliation Plan,
Cross-functionalData Review Plan, with input from cross-functionalstudy team
- Plans and oversees execution of User Acceptance Testing.
- Defines Electronic Data Transfer Specifications
- Ensures study compliance with SOPs and regulations and develops study-specific training for
internaland external study team
- Reviews clinical study protocols and provides input
- Reviews vendor RFIs, RFPs, proposals, and contracts and provide input
- Prepares and delivers presentations at internal and external meetings
- Oversees activities of a CDM team on multiple studies, including internal staff and vendors
- Evaluates and mitigates risks to timelines and quality
- Provides input regarding project resource requirements
- Responsible for all aspects of the CDM study deliverables
- Provides SAS programming support to review and validate legacy SAS code that was developed for DM tasks such as complex/specialty data listings, extract programs, SAS dataset to CSV file conversion, etc.
- Develops complex data listings on an as needed basis
- Prefer B.S. (or equivalent degree) in a scientific or allied health field.
- 4-6 years of relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent comparable background
Job Location: Cambridge, MA
Please send resumes to email@example.com