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Clinical Trial Operations Manager - contract

Posted on Aug 24, 2019 by Michael Bailey Associates - Zurich

Not Specified, Switzerland
Research
19 Sep 0001
Annual Salary
Contract/Project

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 life cycle 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

Please apply now by sending a word document of your CV or contact Neha Sharma.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Reference: 748714365

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