We are hiring a Sr. Clinical Data Associate to be located in South San Francisco, CA!
San Francisco Metro Area, CA
- Perform all data management tasks as appropriate including, but not to be limited to: data review and query management to ensure that quality standards are achieved.
- Perform reconciliation of the clinical database against safety data, laboratory data and other third party data as appropriate Participates in the development, review and implementation of departmental SOPs, templates and processes
- May have project oversight of internal clinical data associates
- Contributes to technical infrastructure of data management
- Review clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete or implausible data
- Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification/correction to the database as required
- At least 4 years of Clinical Data Management experience in a biotech, pharma, or CRO.
- Bachelor degree in Life Sciences, Computer Sciences, Mathematics or health-related field preferred
- Good understanding of pharmaceutical industry, clinical trial development/drug development and the role of DM
- Good working knowledge of ICH, FDA, and GCP regulations and guidelines
- Prior experience with detailed documentation processes