Senior Clinical Trial Project Manager (m,f,d | 80-100%)

regenold GmbH; GVV Müllheim-Badenweiler; Remote; EUR 90,000 - 120,000; Full time

Benefits offered by this job

JobRad

Hansefit

Shuttle Transfer Freiburg-Badenweiler

Company pension scheme

Capital-forming benefits

Job summary

regenold GmbH seeks a Senior Clinical Trial Project Manager to lead end-to-end management of clinical trials for pharmaceutical and medical device projects. You will own setup, regulatory compliance, and sponsor communications, coordinating CROs and external vendors to ensure timelines and quality.

The role requires strong GCP knowledge and fluent German and English communication, with 6+ years in pharmaceutical trials and additional device study experience.

Qualifications

• 6+ years of hands-on experience in managing pharmaceutical clinical trials.
• Solid experience in medical device studies.
• Proven track record in senior roles such as Senior Clinical Project Manager / Lead.
• Excellent written and verbal communication in German and English.

Responsibilities

• Take full responsibility for setup and operational management of clinical trials for pharma and medical device sectors.
• Oversee sponsor relationships, vendor management and CRO oversight.
• Prepare and manage CTA submissions and deficiency communications.
• Establish and maintain clinical trial communication structures with stakeholders.
• Lead end-to-end study management from planning to close-out to ensure timelines and quality.
• Coordinate investigational product management and monitor CRO performance.

Skills

Project management

Regulatory compliance

Stakeholder communication

Budget negotiation

Vendor management

GCP knowledge

German and English communication

Education

Degree in Life Sciences or equivalent

Job description

Senior Clinical Trial Project Manager (m,f,d | 80-100%)

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

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

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

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

• 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 …