An opportunity has opened for a Contract TMF Specialist to join an established Pharma company for 12 months in Hertfordshire. The TMF Contractor is responsible for supporting eTMF leads and business stakeholders effective and efficient TMF operations.
- Oversight and management of the end to end activities involved with the Quality Control review process to ensure study TMFs are of the highest quality and inspection ready and meet compliance specifications according to regional regulations and ICH guidelines.
- Managing the activities associated with the TMF business process, including continuous improvement activities and metrics.
- Conduct oversight of the eTMF vendor and related TMF setup and maintenance processes, eTMF user support and training.
- Engagement with Eisai functional and CRO stakeholders to deliver an inspection ready TMF
- Line management responsibility for the recruitment, training, development, and performance review of the UK TMF staff
Skills and Requirements
- Education to B.Sc. level or equivalent preferred
- Demonstrated experience in the pharmaceutical industry, preferably in regulatory operations or clinical development/operations, with in-depth knowledge of TMF process and clinical documentation
- Experience with Clinical Document Management, TMF/eTMF, and/or Clinical Quality Control desired
- Must have a detailed knowledge of domestic and international regulatory requirements (including ICH and GCP guidelines)
- Knowledge/understanding of TMF requirements and technologies to support document collection and archiving; eTMF experience preferred.
In case you have difficulty in applying or if you have any questions, please contact Jack O'Neill at 0203 846 0646 or upload your CV on our website - www.proclinical.com/send-cv