Description
TMF Manager Outsourced Studies (m/f/d)
Reference: -en
Start: asap
Duration: 9 MM++
Main tasks:
- Support the definition and refinement of the document management strategy for outsourced TMFs, including TMF sponsor oversight activities.
- 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.
- Continuously oversee and identify room for improvement for document management processes of outsourced TMFs.
- Lead improvement and innovation initiatives in a matrix organization.
- Act as Business Lead to manage the implementation of a Next Generation DMS in close alignment with IT and business functions:
- Orchestrate business requirements for fully outsourced TMFs across and identify achievable business benefits;
- Coordinate and participate in system testing activities such as User Acceptance and Performance Qualification Testing to ensure business benefits are reflected
- Support the design of TMF training concept(s) and training material:
- Provide input to technical teams for TMF migration, conduct migration testing in particular for TMF sections previously outsourced to CROs;
- Plan, prepare and oversee rollout and change management activities (communication and training).
Main qualifications
- Minimum Bachelor’s Degree in Life Science/Healthcare or equivalent
- 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
- Experience in Clinical development/clinical operations
- First 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 both independently
Main advantages:
- You will work in an international environment
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Emina Mustafic
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