Pioneering Innovative Therapies to Patients with Life-threatening Diseases
Celyad is a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies. Our ambition is to develop best-in-class cell therapies through novel targets and technology platforms to offer new treatment options to cancer patients.
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 Belgium and in the United States, Celyad offers a stimulating working environment built around teams of highly motivated experts. Our Company collaborates with leading institutions to explore the full potential of our CAR-T therapy candidates and technology platforms.
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:
FREELANCE CLINICAL TRIAL MANAGER
The successful candidate will be based in Belgium and will report into the Head of Clinical Operations in Mont-Saint-Guibert.
Contract length is from June 2020 to year end, with possible extensions.
Role & 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 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
- Degree in Life Science, biological science, or related area: or equivalent relevant experience acquired within life science industries.
- 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
Skills & Competencies
- Creative and finding ways to get the job done
- Thriving in challenging environments and finds ways to remove obstacles to complete enrollment and deliver a robust patient data package
- Flexible mindset capable to manage change and deal with ambiguity
- Proven ability to manage complex projects
- Flexibility to re-prioritize workload to meet changing timelines
- Excellent communicator able to raise the profile of clinical studies within sites and create advocates for recruitment
- Autonomous, pro-active and hands on personality.
- Driven to achieving highest results in challenging timeframe
- Efficient in planning and executing work: orchestrate multiple activities at once
- Team player, able to navigate thru a matrix organization in multi-cultural environment
For more information about this position or about the Company, please contact us by email at email@example.com