Clinical Trials Manager

1 day ago

Bristol, United Kingdom North Bristol NHS Trust Full time

Job summary

Applications are invited for the post of Clinical Trials Manager in the the Academic Respiratory Unit. The unit spans across both North Bristol NHS Trust and the University of Bristol and is based in the Learning & Research building at Southmead Hospital. We design, lead and deliver research into a wide range of respiratory conditions, with a particular focus onclinical studies and trials. Our unit has particular interests in pleural disease, airways diseases such as asthma and COPD, and interstitial lungdisease. Our Unit's objective is to play a positive role in advancing the understanding and treatment of lung disease for people everywhere.

The post holder will be funded to work with the Chief Investigator, Research Manager and other clinical and non-clinical academics within the ARU to ensure that the clinical trials that are assigned to them are delivered to time and target; within budget; and conducted in compliance with regulatory requirements, good clinical practice (GCP), and the study protocol.

Main duties of the job

To lead clinical trial project management for designated trials within the ARU including development, set up and approvals, monitoring of progress, quality and compliance, dissemination and close out.

About us

North Bristol NHS Trust employs over 12,000 staff providing healthcare to the residents of Bristol, South Gloucestershire and North Somerset from our award-winning hospital building at Southmead. We are the regional Major Trauma Centre, and an internationally recognised centre of excellence in a range of services and major specialities. Our vision is that by enabling our teams to be the best that they can be, we will provide exceptional healthcare, personally delivered.

North Bristol NHS Trust values all people as individuals. We aim to be an anti-discriminatory organisation and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We welcome applicants from all underrepresented groups.

Job description

Job responsibilities

This role is central to the development and delivery of specific NIHR Portfolio trials carried out and sponsored by North Bristol NHS Trust. The post holder will be responsible for the set up, delivery and close down of specific studies adopted onto the NIHR portfolio, in accordance with local, national and international legislation. It will be the post holders responsibility to ensure studies are delivered in line with agreed targets with R&D, including financial planning. Their research knowledge and project management skills will ensure a well informed, coordinated support mechanism is provided to researchers and clinicians in the research team.

Please see attached job description and person specification for full details.

Person Specification

Education/Training/Qualifications

Essential

BSc / BA in science/pharmacy/nursing/social sciences/research or management or equivalent

Knowledge/Skills/Abilities

Essential

Evidence of financial and target management for delivery of clinical trials Evidence of managing data management and compliance challenges

Education/Training/Qualifications

Essential

Significant experience working in a research environment Knowledge and experience of risk assessments for clinical trials

Work Experience

Essential

Experience completing IRAS documentation and conducting all aspects of study set up Evidence of advanced organisational and project management skills Experience monitoring and auditing studies to ensure they comply with all relevant legislation Ability to work across both NHS and non-NHS organisations Experience of MHRA inspection

Knowledge/Skills/Abilities

Essential

Advanced communication skills, verbal & written, to include report writing and record keeping Advanced knowledge of ICH-GCP (Inc UK Statutory Instruments) Understanding of the application of research within clinical and research governance Facilitation of development of other staff

Personal Qualities/Special Circumstances

Essential

Evidence of continuing professional development

Desirable

Ability to be mobile to meet the demands of the post

Knowledge/Skills/Abilities

Desirable

Demonstrates an appreciation of how the Trust Organisational Objectives are underpinned by research

Personal Qualities/Special Circumstances

Essential

Demonstrates an ability to work autonomously while co-ordinating multiple projects

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