Job Summary
A pharmaceutical company is searching for a person to fill their position for a Telecommuting Clinical Study Lead Document Management Associate.
Must be able to:
- Attend and support file audits and liaise with Quality Assurance (QA) to resolve audit findings as appropriate
- Support the set-up, maintenance, and closure of Trial Master File (TMF) repositories
- Process clinical study documentation in accordance with SOPs, OGs, GCP, and ICH guidelines
Must meet the following requirements for consideration:
- Expertise in Microsoft Office Suite and Adobe Acrobat
- Six years of demonstrable records management experience, specifically eTMF experience in clinical research field
- Ability to learn and apply SOPs and process governance regulations pertaining to clinical study documentation
