Clinical research Associate
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Medical Devices organization, based in Zuid-Holland Netherlands.
The client is specialised in clinical trials for medical devices.
ROLE DESCRIPTION
You are responsible for monitor activities in medical device trials. The position is based on upcoming clinical trials with our medical device in the Benelux and France.
RESPONSIBILITIES
- Scheduling site visits for monitoring as required.
- Preparation for operational activities from site qualification to close-out visits at investigator sites.
- Delivering monitoring reports.
- Ensuring the validity, correctness, and completeness of clinical data reviewed according trial protocol, and ICH-GCP and ISO 141155.
- Monitoring data in accordance to regulations.
- Maintaining overview of monitored data, queries, protocol deviations and safety events.
- Ensuring compliance to study timelines and budgets.
REQUIREMENTS
- Masters degree in healthcare, biomedical engineering or other life science.
- Trained in ISO14155 or ICH-CGP.
- 2+ years experience in monitoring of medical device trials.
- Fluent un French and English, Dutch would be a plus
- Strong organizational and time-management skills.
- Working knowledge of EU Directives / local regulations / device development, and clinical monitoring procedures.
OTHER
- English and french is required for this position
- A minimum of 2 years of experience in Medical device monitoring is required
- This position is full time
- Willing and able to travel 3/4 of the time across Benelux and France
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Michael Kooiman.
