Description
TMF Manager Outsourced Studies vacancy for a globally operating Basel based company in the pharmaceutical sector.Your experience/skills:
- 3+ years working experience with document management systems and excellent understanding of system structures and generic document management functionality
- 5+ years of experience in clinical development or clinical operations as well as advanced knowledge of clinical documentation and reporting
- Thorough understanding of clinical Trial Master File process, regulatory requirements and Good Clinical Practice, in particular for outsourced TMF filing activities
- Ability to understand technical processes and PC environment including Microsoft suite of products as well as good knowledge of the national and international data protection legislation
- Experience with project work or project management in a global, cross-functional multicultural and international matrix organization
- University degree in Life Science/Healthcare in a relevant field
- Languages: English, fluent in written and spoken, German of advantage
Your tasks:
- Supporting the definition and refinement of the document management strategy for outsourced TMFs, including TMF sponsor oversight activities
- Overseeing the process, system and tool landscape that supports the management of outsourced TMFs.
- Promoting best documentation practice to line functions and providing guidance on document standards for the business functions to support inspection readiness and adherence to Good Documentation Practice
- Ensuring deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs
- Acting as Business Administrator in the electronic Document Management System (eDMS) ensuring appropriate user access restriction, accurate and compliant document creation and document lifecycle management
- Leading improvement and innovation initiatives in a matrix organization
- Acting as Business Lead to manage the implementation of a Next Generation DMS in close alignment with IT and business functions
Start:
Duration: 10MM+
Location: Basel, Switzerland
Ref.Nr.: BH17629
Does this spark your interest? Then take the next step by sending us your CV and a contact telephone number on which you are reachable during working hours.
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As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
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