Trial Master File (TMF) Operational Excellence Communication and Training Manager NOVJP00029692 (m/f)

REFERENCE NUMBER:

404195/29

MY DUTIES:

-Responsible for the development and implementation of the communication and training campaign on Clinical Documentation including Trial Master File within the Novartis organization under the leadership of the TMF Operational Excellence Head
-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 Novartis 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
-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

MY QUALIFICATIONS:

-Bachelor’s degree required; Advanced degree in life science preferred with profound experience in clinical operations and / or clinical document management
-Fluent English (oral and written)
-Thorough knowledge of clinical development process, regulatory requirements and Good Clinical Practice
-Novartis 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
-Ability to learn new systems readily
-Strong computer skills (EXCEL, MS Word) required
-Excellent attention to accuracy and details
-Excellent communication, organization and tracking skills
-Strong operational skills and demonstrated ability to meet timelines
-Proven networking skills and ability to train col-leagues
-Strong interpersonal skills
-Ability to work under pressure
-Resolve issues with minimal supervision and understand when to escalate

MY BENEFITS:

-A city with a high quality of life that perfectly embraces both modern and traditional values
-A highly motivated team and an open way of communication
-A very renowned company

PROJECT INFORMATION:

-As a modern company, our client manages to constantly develop further and break new ground.

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.