Description
In-house - 6 month contract - South San Francisco - 40 hours per weekResponsibilities:
- Review of TMF documentation - TMF contents are transferred from the CRO and multiple vendors to KaloBios, plus documents are submitted directly by KaloBios
- Review of data listings and patient profiles to identify incorrect and inconsistent data. Track proposed queries and follow to resolution. Enter queries directly into the database that are identified by medical monitoring and safety. Verify that the query response satisfactorily address the query and re-issue as required.
- Oversight of the regional CRAs globally. Create performance metrics, address issues identified in QA audits, ongoing re-training, visit coordination and management and direct contact with CRAs on a regular basis
Education and experience:
- BA/BS
- 2+ years experience working in clinical operations in biotech/pharmaceutical industry
- Experience with EDC data management systems
- Excellent written and verbal communication skills