TMF Operational Excellence Communication and Training Manager
Beschreibung:For one of our Swiss Pharma clients we are looking for temporary support as:TMF Operational Excellence Communication and Training Manager (M/F/*)
Responsible for the development and implementation of the communication and training campaign on Clinical Documentation including Trial Master File
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 SOPs
Develop training material, provide training, coaching of knowledge and experience to enhance expertise of fellow Novartis 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
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.
Start: 01.03.2020 // Duration: until 28.02.2021 (1 year contract) // Capacity: 40 h/week onsite
Bachelor’s degree required
Advanced degree in life science preferred with minimum 5 years’ experience in clinical operations and/or clinical document management
Thorough knowledge of clinical development process, regulatory requirements and Good Clinical Practice.
Experience in clinical development process is preferred.
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
Business Fluency in English
Bemerkungen:WANTED: TMF Operational Excellence Communication and Training Manager (M/F/*). In case of interest please contact firstname.lastname@example.org or +49 89 18 90 998-93.Skills:Clinical Data Management, Clinical Reports (Trial-, Study-, Summary-, and Evaluation Reports), English, GCP (Good Clinical Practice)
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