Trial Manager for the LDR BURST Study

Job overview

This is a unique opportunity to lead a high-profile, practice-changing radiotherapy clinical trial within a progressive NHS research environment. The post offers the chance to shape the delivery and expansion of an innovative prostate cancer study from single-centre to international collaboration, working alongside leading clinicians and research partners.

The role provides significant scope for professional growth, strategic influence, and contribution to research that has the potential to directly improve patient outcomes across the UK and Europe.

Main duties of the job

The postholder will take operational responsibility for the delivery and coordination of a complex randomised controlled trial, ensuring milestones are achieved from set-up through to close-down. This includes regulatory submissions, site set-up, recruitment oversight, safety reporting, data quality assurance and study closure. They will coordinate UK and European participating sites, ensure compliance with governance and regulatory standards, oversee monitoring and reporting processes, prepare trial reports, produce a monthly trial newsletter, and proactively seek funding opportunities to support trial expansion. The role also includes supporting grant development and working closely with the Chief Investigator, sponsor, statisticians and clinical teams to deliver the study to time and target.

Detailed job description and main responsibilities

Please refer to the full job description & person spec.

The postholder will:

• Contribute to the development and refinement of clinical trials unit SOPs, policies and operational processes
• Support implementation of robust trial management systems to ensure regulatory and governance compliance
• Provide line management and supervision of junior staff where appropriate
• Support recruitment, training and professional development of trial staff
• Take responsibility for prioritising workload and meeting key milestones
• Prepare for and support audits, monitoring visits and regulatory inspections
• Contribute to corrective and preventative actions within the trials unit
• Maintain own professional development and awareness of developments in clinical trials research
• Actively participate in unit-wide research meetings and portfolio review

Research

The postholder will be responsible for the research coordination and operational management of the trial. This will include:

Trial Design, Set-Up and Regulatory Submissions

• Contribute to protocol development and amendments in collaboration with the CI and statisticians
• Prepare and maintain essential documentation with appropriate version control
• Coordinate submissions and amendments to Sponsor committees, REC, MHRA and other regulatory bodies
• Establish and maintain Trial Master Files (TMF) and Investigator Site Files (ISF) to inspection-ready standards