Senior Clinical Trial Manager --- Home Based - Cell Therapy (Autoimmunity)
I am working with an early-stage biotech based in Germany running two active CAR-T trials. This is a high-impact operational role for an experienced CTM who has worked in cell therapy and thrives in a lean, fast-moving environment.
The Role
You will own end-to-end operational delivery of one or more CAR-T trials - from start-up through close-out - with full accountability for timelines, budget, quality, and CRO/vendor oversight. You will work closely with a cross-functional team and report directly into Clinical Operations leadership.
Key Responsibilities
- Lead all operational aspects of assigned CAR-T clinical trials, managing a cross-functional study team
- Oversee CRO and vendor performance across site initiation, monitoring, and close-out
- Manage study budgets, forecasts, and invoice review in partnership with finance
- Ensure GCP/ICH compliance and inspection-readiness of the Trial Master File
- Develop and maintain study documents, plans, and site training materials
- Provide timely study updates and escalate risks to senior leadership
- Contribute to SOP development and operational best practices
What We're Looking For
- 7+ years in clinical operations across biotech or pharma
- Full study lifecycle experience (start-up through close-out)
- Cell therapy or CAR-T trial experience strongly preferred
- Autoimmunity is a plus - otherwise Rare Disease, Immunology, Immuno-Onco or related technical fields can work
- Solid working knowledge of GCP, ICH guidelines, and EMA/FDA regulations
- Comfortable operating with autonomy in a startup environment
- Based in or willing to relocate to Germany; up to 35% EU travel
- Strong communicator with the ability to manage multiple competing priorities
Other Locations
This is a fully home based position - candidates can also be based:
- Austria, Hungary and Poland
Compensation
- €90,000--€103,000 + 15% bonus + equity
Recruiter Notes
I know Clinical Ops is having a hard time and there are many great people still looking :( Since this is a fully home based position I am expecting this to be competitive.
Here is my advice:
- My clients "unicorn" candidate is someone with Sponsor + CART/CGT + Auto-Immunity + German Speaking.
- I will prioritise those who are closest to this - however I do not expect anyone to have all 4.
- Therefore if you tick some but not all boxes - no problem! Highlight what you can in your CV.
I will review all applications and will reply to everyone. I will not provide individual feedback but I will give you a clear Yes / No so you know about your application.
Thanks for reading and if this is of interest, look forward to hearing from you.
Charles