Senior Project Manager - Clinical Trials
New
United KingdomFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 5–7 years of industry experience, including at least 4 years in full-service clinical project management
- Required Skills
- GCPMS Office
Requirements
- Degree in life sciences or equivalent combination of education and relevant clinical research experience.
- 5–7 years of industry experience, including at least 4 years in full-service clinical project management within a CRO environment.
- Proven experience managing global clinical trials, ideally within Oncology, Rare Diseases, or CNS therapeutic areas.
- Strong working knowledge of GCP, ICH guidelines, and end-to-end clinical development processes.
- Demonstrated ability to manage complex stakeholder environments, including sponsors and senior leadership teams.
- Excellent communication and presentation skills, with fluency in written and spoken English.
- Strong organizational and leadership capabilities with a proven track record of delivering studies on time and within budget.
- Proficiency with clinical and project management systems such as CTMS, eTMF, EDC, and MS Office tools.
- Willingness and ability to travel domestically and internationally as required.
- Strong interpersonal skills with the ability to build effective relationships across global, cross-functional teams.
Responsibilities
- Lead end-to-end project management of global and regional clinical trials (Phases I–IV), ensuring delivery within agreed timelines, budget, scope, and quality standards.
- Act as the primary client-facing representative, managing relationships, communications, and expectations across sponsors and senior stakeholders.
- Oversee cross-functional trial execution, coordinating activities across clinical operations, data management, safety, medical monitoring, and biostatistics teams.
- Contribute to proposal development, bid defence activities, study costing, and strategic planning during the early study lifecycle.
- Monitor project performance, prepare detailed status reports, and escalate risks, issues, and key deliverables to internal and external stakeholders.
- Ensure compliance with GCP/ICH guidelines and maintain high standards of quality throughout all phases of clinical trial execution.
- Manage study budgets and operational scope, ensuring financial and contractual objectives are achieved.
- Facilitate collaboration between internal teams and sponsor organizations to ensure smooth execution and alignment on study goals.
- Support the development and review of essential study documentation, including protocols, project plans, contracts, and budgets.
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