Who we are and what we do

Founded in 1994, regenold GmbH is an international regulatory service provider with over 100 employees. We support clients worldwide in the development, approval and market access of pharmaceuticals, medical devices and in vitro diagnostics, cosmetics, food supplements and other healthcare products.

We are looking for an individual as soon as possible who can ...

Senior Clinical Trial Project Manager (m/f/d) 80 – 100 %

Do you want to work with us?

Then we should get to know each other!

Your responsibility

In this client-facing consulting role, you will take full responsi­bility for the setup and operational management of clinical trials on behalf of our clients in the pharmaceutical and medical device (including IVD) sectors.

Your main tasks will include:

• Setup of clinical trials on behalf of regenold clients, including:
  • Vendor selection and quali­fication
  • Clinical budget nego­tiation and vendor contracting on behalf of the sponsor
  • Vendor oversight and performance management
  • Clinical trial risk assessment
• Operational management of clinical trials for medicinal products and medical devices (incl. IVDs):
  • Management and over­sight of CROs and other external vendors to ensure success­ful trial conduct
  • Preparation and submission of Clinical Trial Appli­cations (CTA) and management of deficiency communi­cations
  • Establishment and maintenance of clinical trial communi­cation structures
  • Stakeholder management across all functional areas
  • End-to-end study management from planning to close-out to ensure timelines, quality, and compliance
  • Coordination of investi­gational product management
  • Sponsor oversight activities, including review of CRO monitoring reports
• Preparation and quality control of clinical trial documentation as required

At regenold, we work in a client-focused environment that is dynamic and responsi­bility-driven.

If you are someone who enjoys taking ownership, guiding clients with confidence and managing projects independently, this role is for you.

If you prefer purely operational or instruction-based work, it likely isn’t.

Your education, skills, knowledge and experience

• CRA background essential
• 6+ years of hands-on experience in managing pharmaceutical clinical trials, complemented by solid experience in medical device studies.
• Proven track record in senior roles such as (Senior) Clinical Project Manager / Lead, ideally across different settings (Pharma, CRO)
• Strong experience in sponsor oversight and vendor management
• Profound knowledge of GCP and the clinical regulatory environment
• Excellent written and verbal communi­cation skills in German and English
• Strong organizational skills, with the ability to prioritize, multitask, and deliver under pressure
• Degree in Life Sciences or equivalent

Our value promise

• Customer and solution orientation – for us, this is the DNA of a good service provider
• Experience, expertise and worldwide networking in over 90 countries through the regulanet® network*
• Innovative and long-standing customers who are happy to recommend us to others
• A cross-team personal and active, lively teamwork
• An attractive, bright and modern working environment

What you get

• International diversity– in the team and in the projects
• Long-term prospects– for professional and personal development, we offer a wide range of tasks and individually tailored training oppor­tunities right from the onboarding phase
• Flexibility, freedom and personal responsibility – through flat hierarchies, short decision-making processes and family-friendly working time models, with something for everyone …
• One of the most beautiful regions in Germany, also called the Toscana of Germany, on the edge of the Black Forest in the border triangle of Germany / France / Switzerland
• Attractive salary, company pension scheme, capital-forming benefits, JobRad, Hansefit, Shuttle Transfer Freiburg-Badenweiler and much more, promised…

Did we make it? Curious?

Then we look forward to receiving your complete application to [email protected] or on our career portal .

Contact: Elisa Winterhalter / +49 (7632) 8226-146

regenold GmbH, Zöllinplatz 4, 79410 Badenweiler

More information:

www.regenold.com, www.regulanet.com*