We are excited to be working with a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies headquartered in, Belgium. The company is developing a diversified pipeline of allogeneic and autologous CAR T cell therapy candidates for cancer patients with haematological malignancies and solid tumors with the goal to eliminate cancer and improve life.
The ideal CTM requires the drive, initiative and creativity to manage dynamic clinical projects from the beginning to the end. This role must possess a mind-set to succeed in a small, entrepreneurial environment where strategic thinking and resource deployment is executed with precision. The CTM will be involved in clinical trials on the development of CAR-T cell therapies within a stimulating working environment built around teams of highly motivated experts.
The successful CTM will be based in Belgium and will report into the Head of Clinical Operations in Walloon Brabant.
Role & Responsibilities
- 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 compliancy
- 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 & Skills
- Degree in Life Science, biological science, or related area: or equivalent relevant experience acquired within life science industries
- At least 10 years' experience in the space of clinical in a CRO or Pharmaceutical company
- Therapeutic area of expertise in oncology/haematology trials is highly desirable
- Prior Biotech/CRO experience is highly desirable
- Strong knowledge of ICH and GCP rules and of the complete clinical trials process
- Flexible mind-set capable to manage change and deal with ambiguity
- Proven ability to manage complex projects
- Flexibility to re-prioritize workload to meet changing timelines
- Autonomous, pro-active and hands on personality