About this role
Job summary
THIS POST IS FIXED TERM/SECONDMENT FOR 18 MONTHS DUE TO MEET THE NEEDS OF THE SERVICE
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.
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.
Job description
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
Essential
- 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
Essential
- 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.
Certificate of Sponsorship
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details
Employer name
Betsi Cadwaladr University Health Board
Address
Ysbyty Gwynedd Bangor
Bangor
LL57 2PW
United Kingdom
Employer's website
https://bcuhb.nhs.wales/train-work-live/ (Opens in a new tab)