Our leading phrmacutical client is looking to recruit a TMF Document Manager on a lucrative contract basis.
Be responsible for 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 area or project. Scope of this profile applies to Clinical Documents relevant for Regulatory Submissions.
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/or oversee the process, system and tool landscape that supports the management GCP relevant documentation within a defined business process area. Manage system and/or process Implementation in collaboration with Business and IT Functions.
3. Act as Business Analyst/Lead to manage the implementation of Document Management Related Applications:
o Orchestrate business requirements across company and identify achievable business benefits
o Coordinate and participate in system testing activities such as User Acceptance and Performance Qualification Testing to ensure business bene-fits are reflected
o Support the design of training concept(s) and training material
a. Provide input to technical teams for migration and support migration testing
b. Plan, prepare and oversee rollout and change management activities (communication and training)
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 lifecycle management in close collaboration with system support and business functions.
The above responsibilities are to a large extent based on interdisciplinary topics and re-quire the employee to liaise, cooperate with and coordinate numerous related functions such as internal Clinical Operations functions, CRO representatives, IT.
Education: Minimum Bachelor's degree in life science/healthcare or equivalent
Languages: Fluent English (oral and written), German of advantage
o Thorough knowledge of clinical Trial Master File process, regulatory requirements and Good Clinical Practice, in particular for outsourced TMF filing activities
o At least 4 years in clinical development/clinical operations
o At least 2 years working experience with document management systems and excellent understanding of system structures and generic document management functionality
o Advanced knowledge of clinical documentation and reporting
o Good understanding of technical processes and PC environment including Microsoft suite of products
o Knowledge of the national and international data protection legislation
o Advanced ability to work independently
o Experience with project work or project management in a global, cross-functional multicultural and international matrix organisation
o Excellent communication, organization and tracking skills
You MUST be eligible to work in Switzerland. Learn more
- Agency: Key People
- Reference: MC25157
- Posted: 13th November 2020
- Expires: 11th December 2020