Clinical Trial Manager

NHS Blood and Transplant

Information:

This job is now closed

Job summary

An exciting opportunity has arisen, to join our Clinical Trials Unit (CTU) at our Cambridge or Oxford Centres.

We welcome requests for flexible working in-line with NHSBTs Flexible Working Policy. Staff in the clinical trials unit currently combine time in the office and remote or home working.

The NHSBT CTU holds full registration with the UKCRC and has expertise in all aspects of clinical trial planning, set up, conduct, analysis and publication. We collaborate with researchers in the design, conduct, analysis and publication of clinical trials and other prospective studies, primarily in the fields of transfusion medicine, organ donation and transplantation, tissue and stem cell transplantation.

Main duties of the job

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 multidisciplinary 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 occasionally will 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

At NHS Blood and Transplant, were incredibly proud of the many talented people who come together every day to make our organisation the very best it can be. We have clearly defined values that are centred around offering exceptional care to our donors and their families. We take care of each other too and we focus on building our expertise so we can change lives, provide quality support and offer fulfilling careers. Its an opportunity to contribute to a unique team as part of a service that saves lives 365 days a year. We offer brilliant benefits including 27 days of holiday (plus bank holidays), a comprehensive induction and training programme, and competitive pension scheme. We are passionate about creating an inclusive workplace and aim to reflect the diverse communities we work with and positively encourage applications from all sectors of the community. Three small words, one big difference - Caring, Expert and Quality. Together we'll save and improve more lives than ever

Date posted

26 October 2022

Pay scheme

Agenda for change

Band

Band 7

Salary

£41,659 to £47,672 a year

Contract

Fixed term

Duration

24 months

Working pattern

Full-time

Reference number

000413

Job locations

Oxford Centre

Oxford

United Kingdom

OX3 9DU


Cambridge Donor Centre

Long Road

Cambridge

CB2 0PT


Job description

Job responsibilities

Please view the attached recruitment profile which is a summary of the detailed Job Description and Person Specification.

Please also view the benefits information sheet which details the benefits of working for NHSBT and the hours of work, salary, leave entitlement etc. for this role.

Job description

Job responsibilities

Please view the attached recruitment profile which is a summary of the detailed Job Description and Person Specification.

Please also view the benefits information sheet which details the benefits of working for NHSBT and the hours of work, salary, leave entitlement etc. for this role.

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 ATMPs, 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 ATMPs, IMPs, Medical Devices, tissues and radioactive products.

Employer details

Employer name

NHS Blood and Transplant

Address

Oxford Centre

Oxford

United Kingdom

OX3 9DU


Employer's website

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

Employer details

Employer name

NHS Blood and Transplant

Address

Oxford Centre

Oxford

United Kingdom

OX3 9DU


Employer's website

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

For questions about the job, contact:

Clinical Operations Manager

James Griffiths

james.griffiths2@nhsbt.nhs.uk

Date posted

26 October 2022

Pay scheme

Agenda for change

Band

Band 7

Salary

£41,659 to £47,672 a year

Contract

Fixed term

Duration

24 months

Working pattern

Full-time

Reference number

000413

Job locations

Oxford Centre

Oxford

United Kingdom

OX3 9DU


Cambridge Donor Centre

Long Road

Cambridge

CB2 0PT


Supporting documents

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