About the Role
Parexel is currently seeking a Senior Clinical Trial Manager (SCTM) to join us in the UK, dedicated to a single sponsor. This role will act as a member of the sponsor's Development Operations team. The Clinical Trials Manager will manage individual clinical trials and/or programs as part of the Clinical Trial Working Group.
Responsibilities
* Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a global clinical operations team.
* Demonstrate oversight of CROs and work within a quality framework that supports confirmatory trials.
* Provide direction and leadership in CRO and vendor selection and management.
* Demonstrate knowledge of regulatory start‑up process and planning in support of study start‑up.
* Manage and maintain high‑performing clinical teams.
* Coordinate global clinical trials.
* Provide technical expertise for development of clinical documents (protocols, monitoring plans, clinical trial reports, investigator brochures, etc.) and trial conduct.
* Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management, and Regulatory to ensure operational excellence.
* Be responsible for and manage clinical research activity of the Clinical Operations team.
* Estimate, track, and critically analyze vendor financial spend on studies.
* Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs.
* Provide guidance, direction, and management for site monitoring activity.
* Coordinate patient enrollment activities and mitigation planning.
* Coordinate study supplies with regulatory and clinical supplies functions.
* Negotiate contracts.
Qualifications
* Bachelor's degree in nursing or an equivalent science degree required (science preferred).
* 5 or more years of industry experience in clinical studies (Pharmaceutical, Biotech or CRO).
* Proven track record with relevant clinical trials experience, including strong performance as a CRA in the pharmaceutical industry.
* Proven experience of clinical trial management.
* Experience in CNS and/or oncology is preferred.
* Proven management/leadership of people in a matrixed environment.
* Management of global clinical trials.
* Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations.
* Demonstrated ability to work independently and in a team environment.
* Travel required; must be willing to travel 15–25%, including international travel.
* Proficiency with MS Office (Word, Excel, PowerPoint, Outlook).
* Excellent oral and written communication skills and strong organisational abilities.
Benefits
We care about our people and your passion, as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long‑term careers.
Company Overview
Parexel supports clinical studies across the full range of therapeutic areas and has longstanding partnerships with a vast client base. We have supported the trials of most of today's top 50 best‑selling drugs, while also enabling niche drug developments that are critical to many patients. You’ll be an influential member of the wider team.
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