Clinical Trials Manager

Betsi Cadwaladr University Health Board; Bangor; Sur place; GBP 50 000 - 57 000; Plein temps

Résumé du poste

Betsi Cadwaladr University Health Board in North Wales is seeking a Clinical Trials Manager on a secondment to lead the execution and coordination of clinical trials across single and multi-site settings. You will ensure governance, regulatory compliance, and budget adherence while coordinating a multidisciplinary team including Chief Investigators and data managers.

The role requires NHS trials experience, strong project management skills, and a commitment to high ethical and scientific

Qualifications

• MSc in relevant field or equivalent experience.
• Knowledge of clinical trials lifecycle from setup to closeout.
• Clinical trials terminology and documentation.
• Understanding of NHS clinical research approval process.
• Knowledge of study design.

Responsabilités

• Lead the execution and coordination of clinical trials across sites.
• Ensure trials meet governance, requirements of BCUHB, Sponsors and funders and timelines.
• Oversee quality control and regulatory compliance for studies.

Formation

MSc in relevant field

Experience in NHS trials

Clinical trials terminology

Study design

Description du poste

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.

About us

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.

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.

Job 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.

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.

Head of Research and Development Service

£50,129 to £57,365 a yearper annum, pro rata