Clinical Operations Manager

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.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.

Main duties of the job

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.

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.

Job responsibilities

What we offer:

- NHSBT promotes flexible working opportunities where the rolewill allow.
- 27 days annual leave (pro rata for part-time) plus BankHolidays, increasing to 29 days after 5 years service and to 33 days after 10years.
- NHS pension scheme. The NHS Pension Scheme is a definedbenefit scheme (not dependent on investment returns) Further details andoutline of benefits can be found at: www.nhsbsa.nhs.uk/pensions
- Weve fostered a culture of continuous learning wherecolleagues are well-led, engaged, and encouraged to grow. We support you inreaching your full potential, both in your current role and future career. OurThrive program embodies our commitment to learning and development, offering awide range of activities to support your personal and professional growth. Itsopen to everyone at NHSBT, ensuring you have the resources to succeed and shinein your role.

Tolearn more, please see our recruitment profile, which provides a summary of thejob description and person specification. This can be accessed via the linkbelow, or by clicking Apply if you are viewing this advert on another site.

Person Specification

Qualifications

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

Experience

- 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.

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