Our client, a global pharmaceutical company has an opening for a TMF training professional. Here we are recruiting for a Clinical Documentation Training Manager who will oversee communication and training of TMF rules and governance. This position sits within Clinical Trial Documentation, Governance and Management. You will be reporting to the TMF Operational Excellence Head
- Responsible for the development and implementation of the communication and training campaign on Clinical Documentation including Trial Master File leadership.
- Promote best documentation practice for the duration of clinical research so that these are managed and archived in accordance with GCP guidelines and SOPs
- Develop training material, provide training, coaching of knowledge and experience to enhance employee expertise. Support, attend and present TMF trainings in multiple forums across different line functions.
- Follow up on responses to ensure closure of the questions. Maintain sharepoint including Question and Answer tracker and identify potential trends. Organize regular Question and Answer sessions on TMF Processes, Systems and tools (eg eTRAC, TMF TOC, VirtualTOC, Document Management System)
- Serve as a liaison between process end-users and eDMS / TMF Governance and Management teams to drive user needs assessment workshops, technical solution discussions and implementation plan. Ensure best practice sharing and promote awareness. Pro-actively provide end-user solutions
- Advanced Degree in Life Sciences
- 5 years' experience in clinical operations and / or clinical document management
- Thorough knowledge of clinical development process, regulatory requirements and Good Clinical Practice.
- Advanced ability to work both independently and in a global cross-functional multicultural and international team.
- Excellent understanding of system data structures and Clinical Document Management System functionality
Kontakt: Luchele Mendes +41 (0) 44 215 2051
Michael Bailey International is acting as an Employment Business in relation to this vacancy.