Our client is a clinical stage biotech company leading the development of new therapies for rare diseases affecting the central nervous system. The company’s leading program is currently in an ongoing phase II/III clinical trial in EU and US, with results expected in 2020. In the upcoming months, our client is planning to launch a clinical trial for a second orphan indication.
For more information about the company, please contact us via email@example.com
Founded in Spain, the company is opening a subsidiary in Gosselies (Belgium). In order to strengthen the team in Belgium, we are currently looking for a (m/f):
Clinical Trial Manager
Reporting directly to the Director of Clinical Operations and working closely with the team in Spain, you are responsible for the operational management and the oversight of clinical trials according to the clinical strategy.
Your main responsibilities are:
- Coordinate clinical trial in collaboration with selected CRO.
- Visit clinical study sites regularly and interact with study members.
- Ensure successful execution of the clinical trials on time and on budget.
- Review study related documentation and materials.
- Co-monitor clinical study for protocol adherence and safety with selected CRO.
- Ensure that clinical trial activities are documented in accordance with regulatory requirement.
- Create and maintain effective relationships with KOL.
- Report results and work evolution on a regular basis to the Director of Clinical Operations.
- Master’s or bachelor’s degree in Life Science or equivalent through experience.
- At least 5 years of relevant experience in clinical trials.
- Extensive knowledge of all aspects of GCP and regulations.
- Track record on managing clinical studies on time & on budget.
- Good collaboration, documentation and presentation skills.
- Flexibility, good time management, team-working skills, stress resistant, ability to work proactively and independently.
- Well-developed communication skills, problem solving skills, creative and critical thinking.
- Excellent command of Microsoft Office Tools (Excel, Word, PowerPoint).
- Fluent in English. A good command of French or Catalan is an asset.
- Prepared to travel to Spanish site regularly, clinical investigational sites, conferences and meeting with regulators.
- An interesting position within a high-potential clinical stage biotech company.
- The opportunity to work in a human-sized and multicultural team environment.
- A variety of interesting contacts with international exposure.
- An attractive salary package in line with the position responsibilities and your experience.