Clinical Trial Manager

NHS Blood and Transplant

The closing date is 13 October 2024

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 NHSBTs 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 us

It takes all types of people to deliver the kind of service that saves and improves lives. At NHS Blood and Transplant, youll 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.

Date posted

25 September 2024

Pay scheme

Agenda for change

Band

Band 7

Salary

£46,148 to £52,809 a year

Contract

Fixed term

Duration

18 months

Working pattern

Full-time

Reference number

004867

Job locations

NHSBT

Cambridge Centre

Cambridge

United Kingdom

CB2 0PT


Job description

Job responsibilities

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.

Job description

Job responsibilities

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.

Person Specification

Qualifications

Essential

  • 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).

Experience

Essential

  • 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.
Person Specification

Qualifications

Essential

  • 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).

Experience

Essential

  • 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.

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.

Employer details

Employer name

NHS Blood and Transplant

Address

NHSBT

Cambridge Centre

Cambridge

United Kingdom

CB2 0PT


Employer's website

https://www.nhsbt.nhs.uk/ (Opens in a new tab)

Employer details

Employer name

NHS Blood and Transplant

Address

NHSBT

Cambridge Centre

Cambridge

United Kingdom

CB2 0PT


Employer's website

https://www.nhsbt.nhs.uk/ (Opens in a new tab)

For questions about the job, contact:

Head of Clinical Trial Operations

James Griffiths

James.griffiths2@nhsbt.nhs.uk

Date posted

25 September 2024

Pay scheme

Agenda for change

Band

Band 7

Salary

£46,148 to £52,809 a year

Contract

Fixed term

Duration

18 months

Working pattern

Full-time

Reference number

004867

Job locations

NHSBT

Cambridge Centre

Cambridge

United Kingdom

CB2 0PT


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