I'm working with a clinical stage biopharmaceutical company developing novel, targeted therapeutics that meaningfully improve the lives of patients with cancer. The Director of Clinical Data Management is looking to bring on a Clinical Data Management Consultant for a 6-month contract. The CDM consultant will working remotely however, my client looking for someone locally based in the San Francisco Bay Area.
- Contribute to all aspects of the data management (DM) process
- Assist in the development of project documentation, system set-up and UAT through database lock
- Responsible helping with technical infrastructure of CDM
- Generate/review/approve study documents
- Develop, review, and implement departmental/company SOP templates
- Bachelor's degree in Biology or other health science or equivalent
- 6-10 years CDM experience in pharmaceutical or biotechnology industry
- CRO management experience
- 2-4 years of staff management is a plus
- Strong technical skills: (EDC systems, MS Word, Excel, PowerPoint) and knowledge of industry standards (CDISC, SDTM, CDASH).
- Oncology/hematology experience