Document Control Specialist

vor 2 Wochen

Stuttgart, Deutschland Immatics Biotechnologies GmbH Vollzeit

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

**Your mission**:

- Your main responsibilities will include but are not limited to the following tasks:

- Set-up and maintenance of Trial Master File (TMF)
- Oversight of outsourced TMF set-up and maintenance
- Preparation of the Investigator Site File (ISF)
- Preparation of a TMF Management Plan
- TMF Filing Performance Review
- TMF Archiving
- Support of GCP compliant TMF and ISF for clinical trials, incl. but not limited to:

- set-up and maintenance of tracking tools
- report preparation
- preparation, review or performance of QC for clinical trial documents
- Develop and maintain SOPs, guidance documents & training material

**Your profile**:

- Successfully completed apprenticeship in a life science/ medical field or equivalent education
- 2+years working experience in the clinical research area in the pharmaceutical/ biotech industry
- Demonstrated computer skills, including Microsoft Office and clinical trial systems (i.e., eTMF)
- ICH-GCP knowledge
- Good English knowledge (written and spoken)
- Team-oriented and a strong team player
- Exceptional attention to detail
- High degree of organization
- Independent, accurate working style
- Outside the box thinking and a high degree of flexibility in an environment which is marked by a constant striving for excellence

**Why us?**:
We are a committed and inspired team and cherish the collegial, highly motivated, and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking, and initiative. We believe in supporting our employees’ professional and social skills: We enable them to join conferences and trainings as well as to enjoy our Immatics benefits - e.g., job bike, job ticket, Health Programs, childcare benefits, relocation allowance, Company summer and winter events.

**Notice**:

- We value diversity and inclusion. Immatics N.V. and all Immatics subsidiaries are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

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