Beschreibung
Job Purpose* Responsible for the development and implementation of the communication and training campaign on Clinical Documentation including Trial Master File within the client organization under the leadership of the TMF Operational Excellence Head.
Major Activities
* Support the TMF Operational Excellence Head to define the document management training and communication strategy for the Clinical study documentation including the Trial Master File, and the oversight of the process, systems and tools for Headquarters and Country Organizations.
* Promote best documentation practice to line functions to ensure that documents created/generated in the course of clinical research are managed and archived in accordance with GCP guidelines and the client SOPs
* Develop training material, provide training, coaching of knowledge and experience to enhance expertise of fellow the client colleagues. Support, attend and present TMF trainings in multiple forums across different line functions. Collaborate with training teams in different line functions to deliver training as appropriate
* Manage the TMF mailbox including addressing questions and liaising with CDGM SMEs as needed. 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
* As TMF Operational Excellence representative, may participate in global cross-functional business process performance or clinical development improvement initiative.
* Continuously seek room for improvement on existing training concepts and material, and initiate and lead improvement initiatives
Ideal Background
Education (minimum/desirable):
* Bachelor's degree required; Advanced degree in life science preferred with minimum 5 years' experience in clinical operations and / or clinical document management
Experience/Professional requirement:
* 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
Michael Bailey International is acting as an Employment Business in relation to this vacancy.