Title: Lead Clinical Data Manager
Location: South San Francisco, CA
Type: 12+ Month Contract
A mid-sized pharmaceutical company is searching for a Lead Clinical Data Manager to perform CRO oversight as well as some hands on data management for several oncology trials in different phases.
Role and Responsibilities:
- Leads clinical data management activities across one or more studies
- Drives or participates in the development and maintenance of Case Report Form (CRF), CRF Completion guidelines, edit check specifications, data transfer specifications, and database audit plans
- Performs cross-functional User Acceptance Testing (UAT)
- May work with clinical, biostatistics, and regulatory teams to design and develop study documents including Clinical Protocol, Case Report Forms (CRFs) and Statistical Analysis Plan (SAP)
- Supports the interaction with contract data management groups to ensure that data management tasks remain on target per project timelines
- Participates in on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, and discrepancies by working with internal and external stakeholders
- Bachelor's degree in clinical, biological, mathematical sciences or related field is required; an advanced degree is a plus; equivalent experience may be accepted in lieu of the degree requirement
- 6+ Years Data Management
- Must have 1+ Years Lead Experience
- Must have RAVE Experience
- RECIST Criteria Experience is a MUST
- Must have previous sponsor experience and direct experience with CRO oversight
Please note contractors are offered benefits through EPM Scientific (healthcare, vision, dental, 401(k) on a W2 basis)
This role is offered on a W2 basis.
If you are interested in this Lead Data Manager position, please do not hesitate to apply !!!