AdresseLooking to make your mark?
Then consider regenold GmbH!
We are looking for a
Clinical Trial Project Manager (m/f/d)
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.
You can find more information on our homepage: www.regenold.com
Your field of activity
- Setup up of clinical trials on behalf of regenold clients, including:
o Vendor selection and qualification
o Budget negotiation and vendor contracting on behalf of Sponsor
o Vendor oversight on behalf of study Sponsor
o Clinical Trial Risk Assessment
- Management of clinical trials on behalf of regenold clients, including:
successful clinical trial implementation
o Assisting CRO with Clinical Trial Applications (CTA) and CTA deficiency communication
o Setup and maintenance of clinical trial Communication Plan
o Support all aspects of study (from planning to close-out) as required, to ensure adherence and
progress
o Coordinate IMP activities with IMP manager and clinical trial sites
o Organization of team meetings including the preparation of agendas, minutes and tracking of
- Monitoring of clinical trials on behalf of Sponsor (“Sponsor Monitoring”) & review of CRO monitoring
- Management of clinical trial Essential Documents, including:
o QC Review of incoming documents and documents generated within regenold clinical trial team
o Co-ordination of essential document distribution, document review and signature process within
stakeholder team
o Supervision of the TMF manager during setup up and management of Sponsor’s Trial Master
Ideally, you should have the following skills and knowledge
- Degree in Life Science or comparable
- Several years of experience in clinical research in roles such as CRA, study coordinator or project
- Working knowledge of GCP
- Excellent written and oral communication skills in German and English
- Good organizational abilities, ability to prioritize and multitask
- Flexibility to seek a tailored approach adapted to clients’ specific needs
What makes us tick
- 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 family-like and personal team spirit in a 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
- One of the most beautiful regions in Germany, on the edge of the Black Forest in the border triangle of
- Attractive salary, company pension scheme, capital-forming benefits, JOBRAD, etc.
Have we made you curious? Could you fit in with us?
Then we look forward to receiving your completed application at
perspectives@regenold.com.
Your contact person is: Christine von der Brelie, +49 (7632) 8226-410.
regenold GmbH, Zöllinplatz 4, 79410 Badenweiler, www.regenold.com
