Beschreibung
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)
- Discuss & agree with CS on electronic delivery plan of TMF documents (timing of document availability, delivery routes (eg through secured electronic gateways), scanning activities if required, timing and content of quality checks, any required paper originals to be filed, and responsibilities)
2. Support CS in the maintenance of trial documentation:
- Work with documentation group and/or CRAs/CROs to resolve issues identified during electronic document uploads into internal systems
- Review eTMF content, provide eTMF content reports to CS on regular basis for review; help 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.