Principal Clinical Data Manager
|Location||Los Angeles, OR San Francisco|
|Category||IT APP/ Dev|
Our Biotechnology client has experienced tremendous success with their Oncology drug and need to add more resources. They have an immediate need for a Principal Clinical Data Manager on a full-time regular hire basis in Los Angeles, OR San Francisco. You will be responsible for leading study data management activities including, but not limited to, coordination of CRF design, development, review and sign off.
The individual may participate in reviewing vendor audit plan and statistical analysis plan as needed; may participate in vendor qualification and monitoring vendor performance.
- Reviews and approves CRO generated Data Management documents
- Coordinates databases live and close out activities with the CRO
- Provides guidance to CRO to manage query flow and implements quality control plan
- Reviews listings to identify data discrepancies and tracks resolutions
- Works with Study team to design mock CRFs based on the protocol
- Leads database design, implementation, and testing activities
- Supervises all Data Management deliverables and associated timelines with the CRO to ensure a quality database lock
- Co-ordinates with Clinical Operations, Biostatistics, Statistical Programming, Safety, and other departments, as needed, to resolve data issues
- Bachelor’s Degree in a biological sciences or other medically related areas
- Data management experience in the biotechnology/pharmaceutical industry
- Familiarity with data management software (e.g. Medidata, Oracle Clinical)
- Working knowledge of coding dictionaries – MeDDRA and WHODRUG
- Knowledge of Oncology clinical trials preferred
- Nursing Background preferred
- Vendor Management experienced preferred
- Familiarity with SAS preferred
- Excellent organizational skills and ability to prioritize tasks; able to work under tight timelines
- Possess excellent written and verbal communication skills
- Anticipates change and reacts quickly and intelligently to accommodate business needs.