Clinical Trials Manager

Eye Screening; Bangor; Hybrid; GBP 50.000 - 57.000; Teilzeit

Zusammenfassung

Betsi Cadwaladr University Health Board (BCUHB) North Wales invites applications for the Clinical Trials Manager, Band 7. The post supports day-to-day management of studies from grant applications to final reports, across multiple sites in the UK.

This fixed-term secondment spans 18 months and requires careful budget and governance adherence. The role emphasizes leadership in trial coordination, data management, and regulatory compliance, within UK health research frameworks.

Qualifikationen

• MSc in relevant field or equivalent experience and training.
• Knowledge of the requirements of clinical trials during their life cycle from set up to close out
• Clinical trials terminology and documentation.
• An understanding of the clinical research approval process in the NHS.
• Knowledge of study design.
• Recent experience and knowledge of working in the NHS.
• Significant experience of protocol driven quantitative research in a health related field.
• Experience of managing a research project.
• Previous managerial experience.
• Previous direct clinical trials and/or project management experience.

Aufgaben

• Lead the execution and coordination of both small single site and large multi-centre clinical trials from development stage.
• Ensure trials are managed in line with governance policies and GDPR 2018.
• Coordinate initiation, day-to-day running and closure of studies with cross-functional teams.
• Develop and review trial documents and SOPs to ensure regulatory compliance.
• Work with Chief Investigators, data managers, statisticians and trial teams across UK sites.

Kenntnisse

NHS experience

Clinical trials

Study design

Project management

Research experience

Ausbildung

MSc in relevant field

Jobbeschreibung

Main area Research Grade Band 7 Contract 18 months (Fixed term for duration of trial - Meet the needs of the service) Hours Part time - 7.5 hours per week Job ref 050-AC293-1126

Employer Betsi Cadwaladr University Health Board Employer type NHS Site Ysbyty Gwynedd Bangor Town Bangor Salary £50,129 - £57,365 per annum, pro rata Salary period Yearly Closing 17/11/2026 23:59

Clinical Trials Manager

Band 7

If you relish a challenge, have a passion to help others or simply fancy a fresh start, then Betsi Cadwaladr University Health Board (BCUHB) North Wales, has all the right ingredients. The largest health organisation in Wales, providing a full range of primary, community, mental health, acute and elective hospital services for a population of around 700,000, across North Wales . Join our team and get the support you need, in line with our Organisational Values and ‘Proud to Lead’ competence framework.

The organisation is currently undertaking a comprehensive operating model review and change programme to ensure we are best positioned for the future, creating exciting opportunities to shape how we work and deliver for the people of North Wales.

Enjoy being part of working with engaged leadership at all levels, and be assured we are committed to promoting equality and diversity, and are proud to welcome applicants under the “Disability Confident Employer” scheme. We also offer a number of family-friendly benefits, including work-life balance policies.

Please check your email account regularly. Successful applicants will receive all recruitment related correspondence via the email account registered on the application form.

Applications may be submitted in Welsh. Applications submitted in Welsh will not be treated less favourably than an application submitted in English.

Job overview

IF YOU ARE INTERESTED IN APPLYING FOR THE SECONDMENT POSITION, YOU MUST OBTAIN PERMISSION FROM YOUR CURRENT LINE MANAGER PRIOR TO APPLYING FOR THIS POST.

The Post holder will be responsible for the day to day management and coordination of studies from grant applications to final report on behalf of Chief Investigators within BCUHB. The post holder will be required to manage one or more studies and will ensure the studies complete on time, to target and within budget. The trial manager is responsible for all quality control / assurance processes relating to the study and trial management and will play a pivotal role in ensuring the studies are conducted to the highest ethical, scientific and regulatory standards.

Main duties of the job

The Post holder will lead the execution and coordination of both small single site and large multi-centre clinical trials from development stage. They will ensure that the trials are managed in line with the research governance policies, requirements of BCUHB, Sponsors and research funders, within the UK policy framework for health and social care research and General Data Protection Principles (GDPR 2018).

The Clinical Trials Manager will work closely with a multi-disciplinary team including Chief Investigators, Principal Investigators, research delivery staff, data managers, administrators and statisticians at Betsi Cadwaladr University Health Board as well as hospital sites across the UK; and all relevant clinical trials units in the UK.

Working for our organisation

If you relish a challenge, have a passion to help others or simply fancy a fresh start, then Betsi Cadwaladr University Health Board (BCUHB) North Wales, has all the right ingredients. The largest health organisation in Wales, providing a full range of primary, community, mental health, acute and elective hospital services for a population of around 700,000, across North Wales . Join our team and get the support you need, in line with our Organisational Values and ‘Proud to Lead’ competence framework.

Enjoy being part of working with engaged leadership at all levels, and be assured we are committed to promoting equality and diversity, and are proud to welcome applicants under the “Disability Confident Employer” scheme.

Please check your email account regularly. Successful applicants will receive all recruitment related correspondence via the email account registered on the application form.

The ability to speak Welsh is desirable for this post; Welsh and/or English speakers are equally welcome to apply.

Applications may be submitted in Welsh. Applications submitted in Welsh will not be treated less favourably than an application submitted in English.

Detailed job description and main responsibilities

COMMUNICATION AND RELATIONSHIPS · Act as a point of contact for all partners, stakeholders and regulators which will be internal and external to BCUHB. E.g. UK Clinical Trials Units, HEIs, Health and Care Research Wales, National Institute for Health Research and BCUHB Research & Development Offices. · Build relationships with Consultants, Clinical Research Fellows and Research Delivery staff both internally and externally communicating complex issues to ensure the research is conducted in accordance with regulation and legislation. · Work with research teams and associated service departments, managers and R&D personnel both internally and externally, to find ways of overcoming systematic barriers to the set-up, recruitment and maintenance of a comprehensive study portfolio.

MANAGEMENT · Support Chief Investigators with the preparation of grant applications and development of protocols and study related materials required to conduct research e.g. Patient Information Sheets, Case Report Forms, Trial Master Site File and Site Files. · Oversee specific budgets, planning for resource needs to ensure that clinical trials are adequately resourced. · Develop and write trial specific procedures including development of Standard Operating Procedures relating to the management of the studies. Ensure developing studies meet all requirements with regards to the UK policy framework for health and social care research and the EU Clinical Trials Directive. TRIAL COORDINATION AND DATA MANAGEMENT: · Co-ordinate and oversee the initiation, day to day running and closure of one or more studies. · Work closely with clinical study teams to ensure studies are conducted in line with the protocol and all applicable regulatory requirements. · Contribute to the development of all study documentation, under the guidance of the CI and Trial Management Group. · Develop and/or review other essential clinical research documents including patient information sheets/letters, informed consent forms as well as regulatory paperwork ensuring compliance with relevant SOPs, legislative requirements and guidelines in accordance to BCUHB Policies and Procedures and Good Clinical Practice .

Person specification

Qualifications

• MSc in relevant field or equivalent experience and training. .
• Knowledge of the requirements of clinical trials during their life cycle from set up to close out
• . Clinical trials terminology and documentation.
• An understanding of the clinical research approval process in the NHS.
• Knowledge of study design.

Experience

• Recent experience and knowledge of working in the NHS.
• Significant experience of protocol driven quantitative research in a health related field.
• Experience of managing a research project.
• Previous managerial experience.
• Previous direct clinical trials and/or project management experience.

To work in the UK, all candidates who are not UK or Republic of Ireland (RoI) nationals require sponsorship to obtain either a Health and Care visa or Skilled Worker visa , unless you have permission to work via another route. Non UK / RoI candidates wishing to apply should self-assess the likelihood of obtaining a Certificate of Sponsorship by visiting Work in the UK . If you are eligible for the Health and Care visa, application costs are lower and you do not need to pay the annual Immigration Health Surcharge.

Employer certification / accreditation badges

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Name Lona Tudor Jones Job title Head of Research and Development Service Email address [e-mail] Telephone number 03000847536