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Trial manager for the ldr burst study

Guildford
Royal Surrey NHS Foundation Trust
Trial manager
€46,000 a year
Posted: 27 April
Offer description

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.


About us

Royal Surrey is a compassionate and collaborative acute and community Trust. Recognising that our 5000 colleagues are our greatest strength, we offer a comprehensive health and wellbeing program along with a commitment to developing and advancing your career. Our diverse and welcoming Royal Surrey family will ensure you feel valued from your initial interview through your entire tenure.

We are clinically led and provide joined up care by bridging the gap between hospital and community services alongside regional specialist cancer care. Our main acute hospital site is in Guildford with community hospital sites at Milford, Haslemere and Cranleigh. We provide adult community health services in homes across Guildford and Waverley.

The Care Quality Commission (CQC) has given us an overall rating of Outstanding.

Royal Surrey has a strong reputation and history to build on. We are proud of our achievements and we are investing in our colleagues through our commitment to supporting professional development as well as investing more than ₧45 million in our physical environment and new equipment in the next few years. There has never been a better time to join us.

Although it isn't the Trusts normal practice, adverts may close early, so you are encouraged to submit an application as soon as possible.

A video about the Royal Surrey - https://www.youtube.com/watch?v=R96pMboIYdo


Job 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


Person Specification


Qualifications

* Educated to degree level or knowledge acquired through degree or equivalent experience or training.
* GCP certification in last 2 years


Knowledge and Experience

* Knowledge of setting up clinical trials and project management, acquired through degree or equivalent experience or training.
* Further relevant staff or project management knowledge to post graduate, diploma or equivalent level
* Significant demonstrable experience of working within a Clinical trials setting
* Trial coordination, set up/close out
* Data Management
* Experience of working within a number of different specialities
* Experience of working in a healthcare/hospital setting
* Experience of working at a senior level
* Monitoring of clinical trials


Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

£41,957 to £50,387 a yearper annum pro rata

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