For our Customer Novartis in Basel we are looking for a
TMF Manager Outsourced Studies
Responsible for efficient and appropriate management of Trial Master Files (TMFs) and other TMF related, inspection-relevant documents from creation through archival in compliance with applicable internal and external requirements for studies with an operational model of outsourced and/or other third party TMFs.
* Support the definition and refinement of the document management strategy for outsourced TMFs, including TMF sponsor oversight activities.
* Oversee the process, system and tool landscape that supports the management of outsourced TMFs.
* Promote best documentation practice to line functions and provide guidance on document standards for the business functions to support inspection readiness and adherence to Good Documentation Practice:
* Create and/or update SOPs, Working Practices, Guidance Documents, templates, etc. as applicable;
* Enforce use of standards and adherence to quality by providing training and support to business functions in cooperation with TMF QC Manager;
* Coordinate eDMS Super/Key User community for relevant process area.
* Ensure deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs.
* May act as Business Administrator in the electronic Document Management System (eDMS) ensuring appropriate user access restriction, accurate &compliant document creation and document lifecycle management in close collaboration with system support and business functions.
* Continuously oversee and identify room for improvement for document management processes of outsourced TMFs.
* Lead improvement and innovation initiatives in a matrix organization.
* Act as Business Lead to manage the implementation of a Next Generation DMS in close alignment with IT and business functions:
* Orchestrate business requirements for fully outsourced TMFs across NVS and identify achievable business benefits;
* Coordinate and participate in system testing activities such as User Acceptance and Performance Qualification Testing to ensure business benefits are reflected;
* Support the design of TMF training concept(s) and training material:
* Provide input to technical teams for TMF migration, conduct migration testing in particular for TMF sections previously outsourced to CROs;
* Plan, prepare and oversee rollout and change management activities (communication and training).
* The above responsibilities are to a large extent based on interdisciplinary topics and require the employee to liaise, cooperate with and coordinate numerous related functions such as internal Clinical Operations functions, CRO representatives, IT. Process harmonizations across different Novartis entities requires the initiative for cross-divisional liaison and alignment.
Compliance of TMF relevant documentation as well as efficiency of related processes:
* Timely submission, delivery of high quality TMF documentation enabling regulatory compliance and applications for marketing approval.
* External satisfaction, acceptability of clinical documentation by Health Authorities.
* Efficient use of resources through operational effectiveness of document management and archiving
* External reputation of NVS clinical documentation, with Health Authorities and in the document management and archiving community in general
* Minimum Bachelor's Degree in Life Science/Healthcare or equivalent
* Fluent English (oral and written), German of advantage
* Thorough knowledge of clinical Trial Master File process, regulatory requirements and Good Clinical Practice, in particular for outsourced TMF filing activities
* At least 5 years in clinical development/clinical operations
* At least 3 years working experience with document management systems and excellent understanding of system structures and generic document management functionality
* Advanced knowledge of clinical documentation and reporting
* Good understanding of technical processes and PC environment including Microsoft suite of products
* Knowledge of the national and international data protection legislation
* Advanced ability to work both independently
* Experience with project work or project management in a global, cross-functional multicultural and international matrix organization
* Excellent communication, organization and tracking skills
Working Time: flexible working hours
Start Date: 01.11.2021
Duration: 10 month
Please apply online. For further information about the position, please contact your Kelly recruiter, Mr Franck Maerky (+41 61 270 80 17).