Clinical Operations Manager

NHS Blood and Transplant; England; On-site; GBP 45,000 - 60,000; Full time

Job summary

A leading health service organization in the UK is looking for a Clinical Operations Manager to oversee a diverse portfolio of clinical trials, including the PANDA programme. The ideal candidate will manage project requirements, contribute to strategic decisions, and ensure compliance with trial regulations. Qualified candidates will have substantial experience in clinical trial management and a relevant postgraduate qualification. The role may require travel and irregular hours.

Qualifications

• Substantial experience of clinical trial project management.
• Expert knowledge and experience of regulatory and clinical governance for clinical research.
• Experience of study trial documentation development, including protocol and grant applications.

Responsibilities

• Oversee the delivery of the PANDA programme and other clinical trials.
• Contribute to CTU strategy and direction as part of the CTU Management Team.
• Support the Head of Operations in developing systems for trial administration and quality assurance.

Skills

Clinical trial project management

Regulatory compliance

Budget management

Staff training

Information Technology proficiency

Education

MSc or PhD in a relevant subject

Honours degree in a relevant subject

Tools

MS Office

Databases for clinical trial data

Job description

Job Summary

NHSBT offers an exciting opportunity to work closely with multi-disciplinary research and operational teams, learning from experts across the organisation, and promoting research and developing new proposals to continuously improve experiences and outcomes of our donors and patients.

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.

You will oversee a diverse and exciting portfolio of clinical trials and a committed group of staff, who you will support to develop and learn. A particular focus of this post is PANDA, a programme of work for the prevention of anaemia in pregnancy. Around a third of UK pregnant women develop anaemia caused by a lack of iron, which may lead to general health problems such as excessive tiredness. Anaemia may also increase the risk of a baby being born stillborn, born early, or born small, or increase the risk of blood loss and developmental delay, although there is uncertainty. The PANDA programme aims to find out if giving iron tablets before anaemia develops, reduces these risks.

You will contribute to all aspects of clinical trial conduct, including potentially the development of grant applications. As a member of the CTU Management Team, you will have oversight over CTU activities and contribute to strategies and plans.

You will work with a supportive, motivated group of colleagues and collaborators and learn about organ and tissue donation and transplantation, blood donation and transfusion medicine.

Main duties of the job

As Clinical Operations Manager you will be providing project management support for a portfolio of trials and clinical studies being undertaken by the UKCRC-registered NHS Blood and Transplant (NHSBT) Clinical Trials Unit (CTU). Your responsibilities include :

• Overseeing the delivery of the PANDA programme and other clinical trials, providing project management expertise to meet requirements and deadlines.
• Contributing to CTU strategy and direction as part of the CTU Management Team, including decisions about new proposals and collaborations and the subsequent writing of associated grant applications.
• Supporting the Head of Operations of the NHSBT CTU in developing and implementing effective systems for financial, managerial, trial administration, data management, and quality control and assurance.
• Guiding the CTU and wider clinical research community on the implications for clinical research of clinical trial regulations. These include the Data Protection Act, the Human Tissue Act, the NHS research governance framework, and the regulatory and logistical aspects of international trials.
• Line managing, mentoring, and developing CTU trial managers or trial co-ordinators and administrators, ensuring they are supported and guided as required.
• Assisting in developing and implementing new trial methodologies and technologies to support our novel programme of trials.
• Working with stakeholders to develop and implement standard clinical operation processes to meet the needs of the CTU.

On occasion, you 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.

You will be required to provide cover during operational emergencies.

About You

Experience and Knowledge

• Substantial experience of clinical trial project management.
• Expert knowledge and experience of regulatory and clinical governance for clinical research in the UK and internationally and in ensuring clinical trials comply with these standards.
• Experience of study trial documentation development including protocol, CRFs, manuscripts, reports, preparation of grant and ethics applications.
• Expert knowledge of clinical trial methodology, procedures, and governing compliance such as ICH-GCP and other relevant guidelines.
• Experience of developing, monitoring, and managing budgets across a portfolio of studies.
• Experience of recruiting, managing, and training clinical trial staff including target setting and performance review.
• Experience of working with Information Technology such as MS Office packages and, familiarity with databases and systems used for managing clinical trial data.

Qualifications and Training

• MSc or PhD in a relevant subject. OR equivalent postgraduate specialist knowledge gained through extensive experience in managing a portfolio of clinical trials.
• Honours degree in a relevant subject.
• Demonstrates commitment to own continued professional development (CPD).