Our client, a clinical stage biopharmaceutical company based just outside of Brussels is looking for a Clinical Trial Manager to come on board to join their team. The company’s main purpose is to develop best-in-class cell therapies through novel targets and technology platforms to offer new treatment options to cancer patients. The successful candidate will report into the Head of Clinical Operations.
Job Description & Responsibilities
Job purpose is to drive all assigned clinical operations’ activities related to the clinical studies from protocol summary, study site selection and regulatory activation process to Clinical Study Report:
- Select and activate chosen study sites, establish and maintain an excellent relationship with site investigators and research teams.
- Create and update activities in overall project plan on a regular basis to assure appropriate outcome of clinical trial projects in terms of scope, timelines and objectives.
- Coordination of assigned CRA monitoring activities.
- Ensure study quality/GCP compliance to deliver a rigorous patient data.
- Partner with Clin Ops Director and provide oversight to all vendors or study delivery team, ensuring timely delivery of milestones and budget compliance.
- Propose and implement study process improvements; Participate in the preparation, updating and training of SOPs.
- Liaise with manufacturing, central lab, and other study project stakeholders as needed
- Prepares all external and internal documentation for assigned trials ensuring it is completed in accordance with the study protocol, internal SOP’s and GCP requirements (e.g., Patient Informed Consent Forms, Monitoring Plans, Project Plans).
- Works with the Clin Ops Team to develop and maintain study timelines.
- Responsible for ensuring vendors deliver according to scope of work and review/approve vendor invoices.
Qualifications & Experience
- Degree in Life Science, biological science, or related area: or equivalent relevant experience acquired within life science industries.
- 8-10 years’ experience within the industry with a minimum of 2-4 years’ experience in project management in early phase oncology/haematology trials, prior small start-up company experience in biotechnology highly desirable.
- Strong knowledge of ICH and GCP rules and of the complete clinical trials process.
- Start Date: ASAP.
- Length of Contract: 6 months with possible extension.
- Schedule: Full time on site when the office reopens– 40 hours per week.
- Location: Brussels, Belgium.