Clinical Project Manager

What you'll do

The Clinical Project Manager (CPM) is responsible for the planning, setup, and execution of clinical studies for manufacturers of medical devices and in-vitro diagnostic devices. As a Contract Research Organization (CRO), Qserve closely cooperates with different sponsors in different therapeutic areas. The CPM ensures the development of the necessary study documents, secures ethics- and competent authority approval, and manages the study from the start to the end. The CPM works closely together with other CPMs and leads small diverse teams with Clinical Research Associates (CRAs, both in-house and external contractors) and other team members.

Qserve CRO is a "boutique” CRO with headquarters in the Netherlands. We have an informal culture with direct communication lines and a no-nonsense mentality.

Besides being involved in the day-to-day operations of a clinical study, the CPM is also responsible for the budget, planning, and deliverables of the project and ensures deadlines are met. Besides that, the CPM provides operational support, for example by conducting (co-)monitoring visits and providing trainings. Most studies take place in Europe but some of them might be in the US, China, or other regions. The CPM role includes a broad and diverse set of responsibilities.

Finally, you participate in strategic clinical projects including the writing of study protocols, post-market clinical follow-up plans, and clinical evaluation reports.

Requirements

What you’ll bring to the team

• Technical or scientific degree (MSc or PhD) in a health-related field (e.g. biology, medical, biomedical engineering or similar);
• 3 – 5 years experience as Clinical Project Manager (CPM);
• Significant experience with study start-up, ethics committee (EC) and competent authority (CA) submission, site qualification, initiation, monitoring and close-out and writing and reviewing study documentation;
• Experience with medical devices is a plus;
• Flexible and practical approach;
• Responsible and proactive attitude;
• Fluent in English, another European language is a plus.
  

Interested?

Getting excited about a career as a Clinical Project Manager in the dynamic and innovating world of medical devices? Then please submit your resume and letter of motivation!