Clinical Study Manager Medical Devices
Netherlands / Europe
Whether you are at home or in the office or at a customer, the moment you open your laptop the sponsor questions and site queries in your inbox have your direct attention.
What makes your day as a Clinical Study Manager diverse and challenging is that you manage two to four clinical projects for our customers at the same time. Where one project is in the phase of answering questions from the Ethics Committee, on another project the CRA expects her monitoring report reviewed in return before noon.
In the morning you have a meeting scheduled with the other Clinical Study Managers to discuss each other’s studies and help each other out with any issues. Also, you have a kick-off call with a new client, whereas you are halfway finishing a monitoring report for another client. In the (international) dynamics of your job, you plan the afternoon free for completing some administrative tasks before you set out travelling to a site selection visit to Germany.
Does this sound like your new job? Then Qserve’s CRO, a growing organization with a lot of freedom and also a high level of exposure and steep learning curve, is looking for you:
A Mid-career CRA / Junior Clinical Study Manager with an affinity for medical devices.
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 collaborate with the other CPMs and a small team of in-house and contract CRA’s, conduct (co-)monitoring visits, 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 regions. This is a broad role where you are expected to develop a good knowledge of, and hands-on experience with a large variety of medical device manufacturers (sponsors), medical devices and study designs in all stages of clinical development. Besides the everyday operations, you participate in strategic clinical projects including the writing of study protocols, post-market clinical follow-up (PMCF) plans and part of the clinical evaluation report (CER).
And this is what you will bring:
- 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) with the ambition to take the next step and become a clinical study manager, orcurrently employed as a clinical study manager or clinical study manager with previous site monitoring experience.
- Experience with medical devices is preferred.
- 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 is required.
- Ability to work in small teams with high individual exposure and responsibility.
- Fluent in English and at least one other European language.
- Working permit and driver’s license for The Netherlands.
Qserve is constantly looking for professionals 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 the 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? Please take a look at our career opportunities at Qserve. We would like to get in contact with you!
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 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, regulatory, quality and clinical competences (altogether over 500 years of experience). And last but not least we offer a balanced set of core benefits that we believe are important to all employees.