Document Control Specialist*

at  Immatics Biotechnologies GmbH

72076 Tübingen, Baden-Württemberg, Germany -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate25 Nov, 2024Not Specified29 Aug, 20242 year(s) or aboveGood communication skillsNoNo
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Description:

OVERVIEW

We are currently seeking a Document Control Specialist* to strengthen our Clinical Operations department. You will work in Tübingen or Munich (alternatively home-based in Germany) in an interdisciplinary environment with colleagues from Germany and the US. Your analytical reasoning and action-oriented style as well as your organization and communication skills will contribute to the team’s success.

ABOUT US

Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. Operating from Tuebingen, Munich and Houston, we are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. For more detailed information, visit www.immatics.com.

Responsibilities:

  • Set-up and maintenance of Trial Master File (TMF) and/ or electronic Trial Master File (eTMF)
  • Oversight of outsourced TMF Set-Up and Maintenance
  • Preparation of a TMF Management Plan and associated documents
  • TMF Filing Performance and Quality Review
  • TMF Reconciliation, Close-out and Archiving activities
  • Support of GCP compliant TMF for clinical trials, incl. but not limited to:
  • set-up and maintenance of tracking tools
  • TMF health reporting
  • preparation, review and performance of QC for clinical trial documents
  • Develop and maintain SOPs, guidance documents & training materia


REQUIREMENT SUMMARY

Min:2.0Max:7.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

72076 Tübingen, Germany