Badenweiler , Deutschland
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.
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.
Project Management
Vendor Oversight
Regulatory Compliance
Stakeholder Communication
Budget Negotiation
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
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
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.
Discover our services
Why join us
Customer & solution focus - it’s in our DNA and the foundation of outstanding service.
Proven expertise with global reach - founder of the regulanet® network , connecting us across 90+ countries
Trusted by innovative, long‑standing clients - many gladly recommend us.
Collaborative culture - personable, energetic, and built on active cross‑team teamwork.
Modern workplace - bright, attractive, and designed to help you do your best work.
what we offer
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 …
International teams and projects
Flexible working hours
and remote work
Company pension scheme
(Betriebliche Altersvorsorge)
Hansefit & JobRad
