We bring breakthrough pioneering therapies to patient with life threatening diseases.
Celyad is a biopharmaceutical clinical-stage company, specialized in the development and engineering of cell-based therapies. Our ambition is to develop a unique immunotherapeutic approach to offer new treatment options to cancer patients. Our team is currently focusing on the development of a new T-cell therapy that has the potential to target and destroy 80% of cancer types. Celyad unites passionate people who keep on pushing the boundaries of innovation, leveraging unique scientific know-how from Research & Development to Phase III clinical trials, as well as a strong expertise in cell manufacturing and logistics.
Based in Europe and in the U.S., Celyad offers a nice working environment as well as the opportunity to interact with colleagues and stakeholders involved at each step of the product development. Our Company surrounds itself with the best industrial and academic partners to explore the full potential of its technological platform. At Celyad, we know that every second counts for the patients and their families, and that is what drives us in our work every single day. Ready to take up this challenge?
Great! Celyad is looking for an enthusiastic:
Clinical Research Associate (M/F)
The successful candidate will be based in Mont-Saint-Guibert (Belgium).
You will have the opportunity to enlarge and strengthen our team within Clinical Operations Department, supporting our many projects. As an experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field of clinical research, you will be a productive member of the team. You enjoy start up, enrollment, follow up and closure of clinical trial activities, and mainly monitoring the progress of clinical studies at the site level.
Role & Responsibilities
- Clinical Site Start-up :
- Support with identification of clinical sites
- Preparation of packages for ethical committee (EC) submissions
- Submissions to ECs
- Preparation of site budget, negotiations of site budget
- Organization, preparation, performance, follow-up of Site Qualification visits, Site Initiation visits
- Clinical Site Management :
- Organization, performance, follow-up of trainings
- Organization, preparation, performance, follow-up of Monitoring visits, Close-out visits
- Identification, communication, resolution of site-related matters, issue escalation
- Site leadership
- Development, writing, review of task-related SOPs
- Support clinical supply chain
Qualifications & Experience
- Bachelor or Master degree in (para-) medical or scientific field
- Involvement in study start-up and EC submissions in at least 2 countries
- At least 3 years of clinical research experience including monitoring, or in pharmaceutical data management including activities during data base locks, or as a study coordinator
- Experience with oncology in early phases
- Experience with Advanced Therapy Medicinal Products (ATMPs) is an advantage
Skills & Competencies
- Very strong attention to details
- Work precisely as per procedures, rules and regulations
- Objective and analytical
- Planning & Organizing skills
- Team spirit
- Excellent English, French and Dutch knowledge (“trilingual”, oral and written), additional languages are an asset
- Strong communication skills
- Hands-on attitude
- International travel is required regularly (up to 50%)
- Office based position
For more information about this position or about the Company, please contact us by email at firstname.lastname@example.org