The leading global pharmaceutical company in Switzerland, has created a new opportunity for a Clinical Trial Operations Manager to support efficient management of Trial Master Files (TMFs) and other operational tasks related to outsourced studies.
This is a long term contract role based in the office in Switzerland.
Your other job responsibilities would include:
- 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.
- Prior experience in clinical operations working with document management systems
- excellent understanding of system structures and generic document management functionality
- thorough knowledge of clinical Trial Master File process, regulatory requirements and Good Clinical Practice, in particular for outsourced TMF filing activities
- Advanced knowledge of clinical documentation and reporting
- 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
Please apply now by sending a word document of your CV or contact Neha Sharma on +41 44305 3076 Currently we have a number of roles within the pharmaceutical industry available please contact us to discuss this role further and other opportunities we are currently working on.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.