Clinical Trial Manager – UK (Remote) – FSP
Parexel, Uxbridge, England, United Kingdom
Parexel is currently seeking a Senior Clinical Trial Manager (SCTM) dedicated to a single sponsor to join our Development Operations team and manage individual clinical trials and/or programs as part of the Clinical Trial Working Group. The role offers long‑term job security, opportunities to work on vital clinical studies for leading global biotechs and pharma, and a healthy work‑life balance.
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.
- Maintain knowledge of regulatory start‑up processes and planning in support of study start‑up.
- Manage and maintain high‑performing clinical teams.
- Co‑ordinate global clinical trials.
- Provide technical expertise for the 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 analyse vendor financial spend on study.
- Analyse and develop action plans to address issues with investigational sites, CRAs, and CROs.
- Provide guidance, direction, and management to site monitoring activity.
- Coordinate patient enrollment activities and mitigation planning.
- Coordinate study supplies with regulatory and clinical supplies functions.
- Negotiate contracts with vendors of clinical trial services.
- Review Informed Consent Forms, CRFs, and study related materials.
- Plan and participate in investigator meetings.
- Assist and support data query process.
- Assure regulatory compliance of investigational sites with Jazz Pharmaceuticals’ SOPs and FDA and ICH guidelines.
- Ensure trial master file is current and maintained.
Requirements
- Bachelor’s, nursing degree or equivalent required, science preferred.
- Five 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 (biotechnology, pharmaceutical, CRO, medical device).
- 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; willingness to travel 15‑25%, including international travel.
- Proficiency with MS Office (e.g., Word, Excel, PowerPoint, Outlook).
- Excellent oral and written communication skills and strong organisational abilities.
We care about our people and provide an open, friendly work environment that empowers growth. You will have opportunities to develop your career and explore cross‑functional roles within Parexel.
Apply now to join our team of dedicated professionals.
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Contact Detail:
Parexel Recruiting Team