Description
The leading global pharmaceutical company in Switzerland has created a new opportunity for a Clinical Trial Operations Manager to support the 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 areas.
· 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.
Requirements:
· 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
We welcome applications of consultants' who match most of the above requirements and are available on short notice. There is a competitive Hourly rate available for the contract; alternative market rates are also welcome.
Job Code: 124508
Michael Bailey International is acting as an Employment Business in relation to this vacancy.