Clinical Trial Project Manager in Badenweiler bei Dr Regenold GmbH

Do you want to work with us?
Then we should get to know each other!

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

Clinical Trial Project Manager (m/f/d)
Full-time

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 responsibility
your tasks will include 

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:
o Management of Contract Research Organizations (CROs) and other external vendors to

ensure 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 action items 
Monitoring of clinical trials on behalf of Sponsor (“Sponsor Monitoring”) & review of CRO

monitoring reports 
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 File

your education, skills, knowledge and experience 

Degree in Life Science or comparable 
Several years of experience in clinical research in roles such as CRA, study coordinator or project

manager 
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

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, 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 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
perspectives@regenold.com
Contact Christine von der Brelie / +49 (7632) 8226-410
regenold GmbH / Zöllinplatz 4 / 79410 Badenweiler / www.regenold.com