Clinical Documents Manager- TMF - 12 months contract, Basel
Posted on Oct 3, 2020 by Michael Bailey Associates - Zurich
A new opportunity has opened for enthusiastic clinical operations administrator to support clinical teams in efficient and appropriate management of GxP relevant clinical documents from creation through archival in compliance with applicable internal and external requirements for a defined business process areas.
1. Support the definition and refinement of the document management strategy for Clinical Documentation relevant for Regulatory Submission, such as Clinical Trial Protocols, Clinical Study Reports, etc.
2. Design and oversee the process, system and tools, which support the management of GCP relevant documentation within a defined business processes. Manage system and process implementation in collaboration with other functions.
3. Act as Business Analyst/Lead to manage the implementation of Document Management Related Applications such as identifying achievable business benefits, coordinating and participating in system testing activities, supporting the design of training concepts and training materials
4. Ensure deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs
5. May act as Business Administrator in the electronic Document Management System (eDMS) ensuring appropriate user access restriction, accurate &compliant document creation and document life cycle management in close collaboration with system support and business functions.
Education: Minimum Bachelor's degree in life science/healthcare or equivalent
Languages: 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
prior experience in clinical development/clinical operations
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 independently
Experience with project work or project management in a global, cross-functional multicultural and international Matrix organisation
Excellent communication, organization and tracking skills
Michael Bailey International is acting as an Employment Business in relation to this vacancy.