12 month contract
Senior Clinical Trials Management Associate
Biopharmaceutical company that is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies. The Clinical Operations team is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world.
In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of products.

Essential Duties and Job Functions:

• Assist global trial managers with set-up of central labs and study vendors as required, including liaising with study management CRO to ensure site training and timely initiation
• Performs accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required
• Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
• Review of trip reports generated by CRO CRAs
• Communicates and collaborates with other functional groups including but not limited to Clinical Research, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities
• Assists in the Management of the CRO’s and vendor’s as required
• Assists with the preparation and organization of international investigator meetings
• Assists in preparation of safety, interim and final study reports, including resolving data discrepancies

Experience, knowledge and skills:

• Educated to degree level or equivalent in a scientific discipline
• Previous experience of pharmaceutical clinical trial experience
• CRA experience is highly desired
• Oncology experience is required / CAR-T Cell Therapy would be desirable
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
• Previous experience in clinical research sites/hospitals, CROs, or pharmaceutical companies is desirable
• Knowledge of European regulations for clinical trials is desirable.