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.
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.
Your mission Your main responsibilities will include but are not limited to the following tasks:
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 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.
Karrierestufe
Berufserfahren
Beschäftigungsverhältnis
Vollzeit
Tätigkeitsbereich
Projektmanagement
Branchen
Biotechnologieforschung
Mit einer Empfehlung lassen sich Ihre Chancen auf ein Vorstellungsgespräch bei Immatics verdoppeln.