Badenweiler , Deutschland
Your responsibility, tasks
In this client-facing consulting role, as part of the clinical team you will take full responsibility for the setup and operational management of clinical investigations on behalf of our clients in the medical device and 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 and advising clients with confidence and managing projects independently, this role is for you.
If you prefer purely procedural or methodical work, this role may not be for you..
Your main tasks will include:
Taking responsibility for the setup and operational delivery of clinical investigations for regenold clients in the medical device and IVD field
Selecting, qualifying, and overseeing CROs and other external vendors, including feasibility, budget negotiations, contracting and performance management
Sponsor oversight activities to ensure study quality, compliance and timely execution
Preparing and submitting Clinical Trial Applications and managing requests and deficiency communications
Driving cross-functional stakeholder communication and ensuring effective study governance structures
Managing clinical investigations end to end, from study planning to close-out
Reviewing key study documentation, including CRO monitoring outputs and deviations, ensuring documentation quality throughout the project
Project Management
Vendor Oversight
Regulatory Compliance
Stakeholder Communication
Budget Negotiation
Your education, skills, knowledge and experience
CRA background preferred
6+ years of hands-on experience in managing clinical trials with solid experience in clinical investigations.
IVD experience is beneficial but not essential
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, communicate effectively 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 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, www.regulanet.com
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 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
