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

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.

Responsibilities

• 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

Qualifications

• 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.