Document Control Specialist*
at Immatics Biotechnologies GmbH
72076 Tübingen, Baden-Württemberg, Germany -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 25 Nov, 2024 | Not Specified | 29 Aug, 2024 | 2 year(s) or above | Good communication skills | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
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