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Clinical Research Project Leader

vor 3 Monaten

Karlsruhe, Baden-Württemberg, Deutschland Qserve Group B.V. Vollzeit

Role Overview

The Clinical Research Project Leader is tasked with the strategic planning, initiation, and management of clinical trials for manufacturers of medical and diagnostic devices. As a specialized Contract Research Organization (CRO), Qserve Group B.V. collaborates with various sponsors across multiple therapeutic domains. The Project Leader ensures the creation of essential study documentation, obtains necessary ethical and regulatory approvals, and oversees the project from inception to completion. This role involves close collaboration with fellow Project Leaders and the leadership of small, diverse teams comprising Clinical Research Associates (CRAs), both internal and external.

Qserve Group B.V. operates as a boutique CRO with a relaxed corporate culture that promotes open communication and a straightforward approach.

In addition to managing the daily operations of clinical trials, the Project Leader is accountable for project budgeting, scheduling, and deliverables, ensuring that timelines are adhered to. Furthermore, the Project Leader provides operational assistance, which may include conducting monitoring visits and delivering training sessions. While most studies are conducted in Europe, there may be opportunities in other regions such as the US or Asia. The role encompasses a wide array of responsibilities.

Moreover, you will engage in strategic clinical initiatives, which include drafting study protocols, developing post-market clinical follow-up strategies, and preparing clinical evaluation reports.



Qualifications and Skills

  • A technical or scientific degree (MSc or PhD) in a health-related discipline (e.g., biology, medicine, biomedical engineering, or a related field);
  • 3 to 5 years of experience in a Clinical Project Management role;
  • Extensive experience in study initiation, ethical committee and regulatory authority submissions, site qualification, initiation, monitoring, and closure, as well as drafting and reviewing study documentation;
  • Experience with medical devices is advantageous;
  • A flexible and pragmatic mindset;
  • A responsible and proactive approach;
  • Fluency in English; proficiency in another European language is a plus.

Interested in Joining Us?

If you are enthusiastic about pursuing a career as a Clinical Research Project Leader in the innovative and dynamic field of medical devices, we encourage you to submit your resume and cover letter.