TMF Manager Outsourced Studies
Altran
Basel, CH
vor 2 Tg.

Our offer

  • A permanent contract with the leader in innovation and high-tech engineering consulting
  • A multi-stage model with career opportunities through specialization prospects, as well as with over 45'000 consultants around the world and revenue of EUR.
  • 3.3 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).

  • In Switzerland, Altran employs more than 300 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.
  • Your role

  • Manage the Trial Master Files (TMFs) and other TMF related (migration), inspection-relevant documents.
  • Supervise the process, system and tool landscape that supports the management of outsourced TMFs.
  • Promote best documentation practice and provide guidance on document standards to support inspection readiness and adherence to Good Documentation Practice / Good Clinical Practices.
  • Create and / or update SOPs, Working Practices, Guidance Documents, templates, etc.
  • Enforce the use of standards and adherence to quality, by providing training and support to business functions in cooperation with TMF QC Manager.
  • Work as Business Administrator in the electronic Document Management System (eDMS).
  • Act as Business Lead to manage the implementation of a Next Generation DMS.
  • Your profile

  • Bachelor’s Degree in Life Science / Healthcare or equivalent.
  • At least 5 years working experience in clinical development / clinical operations.
  • At least 3 years working experience with document management systems.
  • Excellent understanding of system structures and generic document management functionality.
  • Thorough knowledge of clinical Trial Master File process, regulations and Good Clinical Practice.
  • Advanced knowledge of clinical documentation and reporting.
  • Knowledge of the national and international data protection legislation.
  • Fluent English (oral and written), German of advantage.
  • If your profile matches the requirements of the position, we will contact you within the next fifteen (15) days of submitting your application.

    Otherwise, please kindly consider that your application is unsuccessful.

    Please note, that we only accept applicants with Swiss or EU / EFTA citizenship or applicants with an existing and valid residence and work permit for Switzerland.

    Altran is an EEO and Affirmative Action Employer of Females / Minorities / Individuals with Disabilities.

    Melde diesen Job
    checkmark

    Thank you for reporting this job!

    Your feedback will help us improve the quality of our services.

    Bewerben
    E-Mail
    Wenn ich auf "Fortfahren" klicke, gebe ich neuvoo das Einverständnis, meine Informationen zu speichern und mir wie in den Nutzungsbedingungen und Datenschutzbestimmungen beschrieben, personalisierte E-Mail Alerts zu schicken.
    Fortfahren
    Bewerbungsformular