Clinical Trials Manager

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.

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.

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/