Clinical Trial Manager

Clinical Trial Manager

Job Summary

An exciting opportunity has arisen, to join our Clinical Trials Unit (CTU) as a Clinical Trial Manager based in Cambridge. This role provides an excellent range of experience in the conduct of clinical trials, providing support for one or more of our trials, from set up to close down.

NHSBT Clinical Trials Unit is a specialist, fully UKCRC-registered CTU delivering a growing, innovative, high quality, multi-centre clinical trials programme, nationally and internationally. NHSBT CTU has expertise in the design, conduct, analysis and publication of clinical trials and other prospective research studies. We collaborate with researchers in NHSBT’s therapeutic areas: transfusion medicine, organ donation and transplantation, tissue, and stem cell transplantation. The team is passionate in their work to save and improve lives through research. The evidence generated directly benefits patients through influencing clinical guidelines and practice in the NHS and beyond.

NHSBT offers an exciting opportunity to work closely with multi-disciplinary research and operational teams, learning from experts across the organisation, and promoting research to continuously improve experiences and outcomes of our donors and patients. It is a friendly place to work with a supportive and collaborative culture and environment, offering great opportunities for career development and the chance to make a real difference to patients.

Main duties of the job

The clinical trial manager will be responsible for:

• The overall management of one or more clinical trials, working with the Chief Investigator (CI) and the Clinical Operations Manager (COM) as part of a multi-disciplinary research team.
• Co-ordinating the design, implementation and management of the clinical trial(s) across multiple participating hospital sites, ensuring timely data collection and Good Clinical Practice (GCP) compliance, and undertaking regular clinical monitoring site visits.
• The maintenance of Trial Master File(s) and study documentation.
• Obtaining all relevant ethical and regulatory approvals.
• Facilitating meetings of trial committees and responsible for ensuring relevant and timely updates for project stakeholders.
• Providing supervision of more junior members of Clinical Operations staff, as required.
• You may be required to travel and spend time away from base, which will involve working irregular hours and overnight stays when required, with prior notice.

About You

Experience and Knowledge

• Experience of research project co-ordination in a clinical / epidemiology / public health research setting and understanding of clinical trials methodology.
• Knowledge of NHS research governance and International Conference on Harmonisation – Good Clinical Practice (ICH-GCP) and other relevant guidelines and regulations governing conduct of clinical trials in UK and internationally.
• In depth Understanding of relevant UK legislation e.g. General Data Protection Regulations, Freedom of information, knowledge of ethical issues, and experience of preparation of ethical submissions.
• Experience of working with information technology using Microsoft Office packages (Word, Excel and PowerPoint), databases or equivalent Systems.
• Knowledge and experience of regulations and the regulatory bodies governing clinical trials, particularly of ATIMPs, IMPs, Medical Devices, tissues and radioactive products.

Please view the attached recruitment profile which is a summary of the detailed Job Description and Person Specification for the full personal attributes we require for the role. You will need to demonstrate these throughout the recruitment process.

Qualifications and Training

• Honours degree in a relevant science / healthcare related subject (including nursing).
• Post-graduate qualification in a relevant subject e.g. MSc or equivalent body of highly developed specialist knowledge gained through formal training and extensive work experience in clinical trials.
• Demonstrates commitment to own continued professional development (CPD).

About Us

It takes all types of people to deliver the kind of service that saves and improves lives. At NHS Blood and Transplant, you’ll join a team of more than 6,000 people who are making a genuine difference to communities, families, friends, relatives and more across the UK. We play a unique and special role in the NHS by helping people do something extraordinary- donate blood, blood products, organs, tissues, or stem cells to save someone in need.

Our three core values are what set us apart. They guide and inspire everything we do.

By being caring, expertly meeting the needs of our patients and our people, and accepting nothing less than the best quality, we can do extraordinary work – and help our people to do something extraordinary in their career, too. Three small words, one big difference - Caring, Expert and Quality. Together we'll save and improve more lives than ever.

You will join us on our journey to create an inclusive workplace and aim to reflect the diverse communities we work with, and we positively encourage applications from all sectors of the community.

What we offer:

• NHSBT promotes flexible working opportunities where the role will allow.
• 27 days annual leave (pro rata for part-time) plus Bank Holidays, increasing to 29 days after 5 years’ service and to 33 days after 10 years.
• NHS pension scheme. The NHS Pension Scheme is a defined benefit scheme (not dependent on investment returns) Further details and outline of benefits can be found at: www.nhsbsa.nhs.uk/pensions ‎  
• We’ve fostered a culture of continuous learning where colleagues are well-led, engaged, and encouraged to grow. We support you in reaching your full potential, both in your current role and future career. Our Thrive program embodies our commitment to learning and development, offering a wide range of activities to support your personal and professional growth. It’s open to everyone at NHSBT, ensuring you have the resources to succeed and shine in your role.

This vacancy will close at 23:59 on Sunday 13^th October 2024

Interviews are anticipated to be held on 24^th/25^th October 2024– subject to confirmation.

For informal enquiries please contact – Name: James Griffiths, Job Title: Head of Clinical Trial Operations, Contact Details: James.griffiths2@nhsbt.nhs.uk