Senior Clinical Trials Management Associate (Oncology & Cell Therapy)
📍 Location: Stockley Park, Uxbridge (Hybrid – 3 days onsite, 2 days remote)
📅 Contract: 12-Month Contract
About the Role
We are seeking an experienced Senior Clinical Trials Management Associate to support the delivery of global Oncology and Cell Therapy clinical studies. This role will play a key part in coordinating study start-up activities, overseeing CRO and vendor performance, supporting site management activities, and ensuring clinical trials are conducted in compliance with GCP, regulatory requirements, and internal procedures.
The successful candidate will work closely with cross-functional teams across Clinical Operations, Clinical Research, Regulatory Affairs, Drug Safety, and external partners to ensure efficient and high-quality study execution.
Key Responsibilities
- Support Global and Regional Trial Managers with study start-up activities, including central laboratory and vendor set-up.
- Liaise with CROs and study vendors to ensure timely site training, activation, and study initiation.
- Conduct accompanied site visits, including Pre-Study Site Visits (PSSVs), Site Initiation Visits (SIVs), and Routine Monitoring Visits (RMVs), alongside CRO Clinical Research Associates.
- Review routine regulatory documentation and study files to ensure compliance with study protocols, GCP, regulatory requirements, SOPs, and monitoring plans.
- Assist with the review of clinical study documents, including protocols, informed consent forms, monitoring plans, case report forms, investigator brochures, abstracts, presentations, manuscripts, and clinical study reports.
- Review monitoring and trip reports generated by CRO Clinical Research Associates.
- Collaborate with internal stakeholders, including Clinical Research, Regulatory Affairs, Drug Safety, Clinical Contracts & Finance, and Materials & Logistics, to support study delivery.
- Support the oversight and management of CROs and external vendors.
- Assist in the planning and organisation of international investigator meetings.
- Contribute to the preparation of safety reports, interim analyses, and final clinical study reports, including data query resolution.
- Complete study-related administrative activities accurately and within required timelines.
Requirements
Essential
- Degree-qualified in a scientific discipline or equivalent experience.
- Previous pharmaceutical or biotechnology clinical trial experience.
- Oncology clinical research experience.
- Strong understanding of clinical trial processes and study management.
- Excellent communication, organisational, and stakeholder management skills.
- Proficiency in Microsoft Word, PowerPoint, and Excel.
Highly Desirable
- Clinical Research Associate (CRA) experience.
- Cell Therapy or CAR-T experience.
- Experience working within a CRO, pharmaceutical company, biotechnology company, or clinical research site/hospital environment.
- Knowledge of ICH-GCP, European Clinical Trial Regulations, and regulatory requirements.
- Familiarity with FDA and/or EMA regulations governing clinical research.
Additional Information
- Hybrid working model with a minimum of 3 days per week onsite.
- Occasional travel required (approximately 1–2 trips per year).
- Opportunity to contribute to innovative oncology and advanced therapy clinical development programmes.