Clinical Site Manager
SIRE 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!
Our client is a professional Medical Devices and Pharmaceutical organization, based in Brussel Belgium.
Our client is a leading company in health and hygiene.
In this position as a Clinical Site Manager you will provide support to implementation of the clinical research operations programme for all therapeutic areas for Medical Devices (in accordance with regulations for Medical Devices).
- Support the Clinical Trial Leader for projects in the EMEA (for the defined therapeutic area by monitoring and reporting on studies progress)
- Maintain the ethical, clinical and scientific standards
- Keep abreast of international legislation and other requirements concerning clinical research. Prepare and submit submissions for the approval of clinical investigations to regulatory authorities and ethics committees
- Keep abreast of developments in clinical research and the clinical literature in therapeutic areas of responsibility
- Assist in preparation of consent documentation where required for the proper scientific evaluation of new or existing products in accordance with all ethical and regulatory requirements for Medical Devices in respect of applicable European and International Medical Devices Regulations.
- Monitor defined clinical studies in accordance with GCP requirements and provide regular feedback to company personnel on the progress of trials.
- Administer the inventory of Investigational Products and control the issue of investigational products to approved sites where necessary.
- Participate in project teams and build relationships with investigators, regulatory bodies and appropriate company personnel
- Maintain compliance with Company SOPs
- Degree in Life Sciences, Health Sciences or related field to Biomedical Engineering or equivalent combination of education and experience.
- 4+ years experience of clinical trials monitoring in a medical company preferably with medical devices.
- Knowledge of clinical study design + management
- Relevant experience in implementation of clinical research studies
- Working knowledge of international regulatory requirements applicable to clinical research. Awareness of research ethics
- Above average oral, written and communication skills
- Dutch English & French writing and speaking
- 100% availability (80% possible)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Hanneke de Koning.