Jocelyn Blackham is recruiting for a Trial Master File Lead to join an innovative Swiss Biopharmaceutical company in the industry at their site based in Lausanne on a contract basis for 24 months. This role can be offered on a remote basis.
Trial Master File Lead Role:
- Develop and improve work processes and systems to support document management, including contributing to SOPs and internal department guidance
- Promote harmonization of document filing and eTMF management across departments
- Supervise the TMF champions initiative and setup of the TMF specialist organisation & management
- Act as Line Manager of the TMF Specialists (2-3 people); managing their workload, prioritizing their activities
Key duties will include:
- Owning and maintaining the Quality Control process of the eTMF; ensure users training and appropriate process execution
- Analysing eTMF issue trends and escalating concerns, and supervising implementation of Corrective/Preventive Action
- Providing support during audits, due diligences and inspections
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- University/College degree level or equivalent in a relevant discipline
- Previous experience in the Pharmaceutical Industry or CRO with previous experience with clinical documents management (process and execution level) in clinical research with good knowledge of TMF, GCP and drug development.
- Extensive knowledge and application of the TMF Reference Model, ALCOA-C standard, Good Clinical Practice (ICH GCP E6 (R2), FDA 21 CFR Part 11), Good Documentation Practices and any other relevant are preferred
- Previous experience in people management highly preferable or previous involvement in team members’ coaching
- Fluency in English required (C1), French is an advantage
This is an excellent opportunity to join an exciting Swiss biopharmaceutical company.
For more information or to apply for this position, please contact Jocelyn on 0041 (0) 800 106 106 or email email@example.com. Please could you send any correspondence in English. Please quote reference 52700 in all correspondence.