Document Manager - Trial Document Specialist

Core responsibilities applicable for studies following electronic Trial Master File (eTMF) procedure:

1. Support Clinical Scientist (CS) in the set-up of an eTMF process for assigned studies, for example and as applicable:

- Set-up of eTMF Table of Content at study start and update as appropriate during study in agreement with CS
- Work with documentation and Monitoring Liaison Manager groups to ensure CRA/CRO is trained on agreed process for eTMF document delivery
- Work with sites to attain required regulatory/essential documentation in a timely manner as required to meet timelines throughout study conduct
- Electronic gateway account creation for external party (CRA, CRO)
- Discusshelp with follow-up of missing/outstanding documents
- Conduct detailed and appropriate quality checks on eTMF documents at defined time points, including any paper originals required
- Scan (or coordinate scanning by vendor), properly name, and import documents into internal systems to ensure availability

Michael Bailey International is acting as an Employment Business in relation to this vacancy.