Clinical Study Manager

Clinical Study Manager

Netherlands/Europe

Qserve is constantly looking for consultants at different career levels with experience in regulatory affairs, quality assurance, clinical affairs, clinical trials or auditing in the area of medical devices and in vitro diagnostic devices. We are a worldwide operating and fast growing regulatory consulting and CRO organization in the medical device sector with our largest base in Europe, and local teams in China and USA.

Is this your DNA? 

Do you find pride in supporting customers in line with professional and ethical values? Do you have a practical approach and like being creative in finding solutions? Do you enjoy the diversity of working with different devices and companies at the edge of innovation?Please take a look at our career opportunities at Qserve. We would like to get in contact with you!

This is what you will be doing at Qserve:

As a Clinical Study Manager at our CRO you lead the planning, setup and execution of clinical investigations for medical devices and in-vitro diagnostic devices. In close collaboration with the Sponsor, you develop the necessary study documents, secure ethics approval and competent authority approval, and manage the study from start-up to close-out. You lead a small team of in-house and contract CRA’s, conduct co-monitoring visits, site audits, and GCP training sessions. Most studies are in Europe but you sometimes step in when help is needed with a study in the US, China or other region. This is a broad role where you are expected to develop a good knowledge of, and hands-on experience with a large variety of devices and study designs in all stages of clinical development. When you are not working in clinical operations, you participate in other clinical projects including the writing of study protocols, post-market clinical follow-up plans and clinical evaluations.

And this is what you will bring:

  • You have a technical or scientific degree (MSc or PhD) in a health-related field, biology, medical, biomedical engineering or similar.
  • 1-3 years’ experience as Clinical Research Associate (CRA) at a medical device manufacturer, biotech company, CRO or in pharma. In addition, 1-3 years’ experience as a clinical study manager or clinical project manager at a medical device manufacturer or device CRO.
  • Experience with study start-ups, ethics submission, competent authority submission, site qualification, initiation, monitoring and close-out and writing and reviewing study documentation.
  • Pragmatic, focus on quality and patient safety. Strong project management skills.
  • Ability to work in small teams with high individual exposure and responsibility.
  • Willing to coach trainee CRA’s as well as experienced in-house and contract CRAs.
  • Experience with medical device studies and good knowledge of ISO 14155.
  • Option to develop training and presentation skills and to develop as a clinical consultant.
  • Experience with clinical data management, safety reporting or site auditing is a pre.
  • Fluent in English and at least one other European language.
  • Working permit and driver’s license for The Netherlands.

Why choose Qserve?

Qserve has an international and dynamic work environment in which you can learn, develop and operate in the innovative, fast moving Medical Device and In Vitro Diagnostics sector. We offer flexibility and diversity in terms of clients, devices, technology, roles (author, reviewer, expert, trainer, auditor, etc.) and projects. Work together, learn from and be part of a strong international team with technical, clinical, regulatory and quality competences (all together over 800 years of experience). And last but not least, we offer a balanced set of core benefits that we believe are important to all employees. 

“Global reach, practical approach, experienced team”

Interested?

Getting excited about a career as a consultant in the dynamic and innovating world of medical devices? Then please submit your resume and letter of motivation to careers@qservegroup.com or use our application form on our website: https://qservegroup.com/en/careers.

For more information about our company you can always visit our website (www.qservegroup.com) or contact our HR department at +31 20 78 82 630.

The position is mainly office-based at our Headquarters in Arnhem (The Netherlands); we expect our consultants to work at the client location as well as that we offer flexibility to work from home; this position requires international travel up to 20% of the time.

How can we help you? Contact us