Head of Operations: Newcastle Clinical Trials Unit

Salary: £57,422 to £60,907 with progression to £66,537 per annum

Newcastle University is a great place to work, with excellent benefits. We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you.

Closing Date: 22 April 2025

Context

NCTU is a thriving academic trials unit, working in collaboration with investigators to design and conduct high quality trials and studies, answering important questions, whose findings bring substantial impact We aim to consistently achieve excellence in trial and study methodology and conduct, playing a pivotal role in diagnostic, therapeutic, treatment and care pathways that successfully deliver on regional, national, and international research priorities.

Current therapeutic areas of expertise include Rare Disease, Respiratory Medicine, Intensive Care, Urology, ENT, Cardiovascular, Surgery, and Oncology, with the remainder of our portfolio arising from other therapeutic areas. The Unit is a key partner in the Newcastle Hosted NIHR Research Support Service.

The Role

The Head of Operations will play a lead role in the development and delivery of operational infrastructure that ensures effective, efficient trial conduct, underpinned by a robust finance and business model, and in line with regulatory and other requirements.     

Acting with a substantial degree of independent professional responsibility, the Head of Operations will have responsibility for the continuous improvement of the unit’s ways of working.  Taking an innovative approach, the role will streamline operational aspects, ensuring high quality and efficient operational processes.

Responsible for service delivery, the role will set quality and professional standards with responsibility for developing a sustainable operating structure that supports excellence in methodological and therapeutic areas and brings long term resilience.

Through the use of digital technologies the role will optimise portfolio management and enable effective, efficient and robust trial and CTU data capture.

Please find a link to the candidate pack here.

To apply for the position, please submit your CV and a personal statement outlining how you are suitable for the role using evidence to highlight how you meet the essential criteria in knowledge, skills and experience as listed in the job description. 

We offer the opportunity to work flexibly between our offices and home, along with core hours and flexible start/finish times. 

Please contact Professor Helen Hancock helen.hancock@newcastle.ac.uk for further information. 

This role is full time, fixed term for 5 years.

Key Deliverables

•    Evidenced excellence in portfolio delivery; trials starting and finishing on time and to budget; compliant conduct   
•    Effective resource and financial management; resource (capacity) in line with trial needs effective resource management underpinned by healthy finances
•    Operational efficiency (within scope of influence); right staff, right trial, right time; compliant processes; effective meetings involving relevant people
•    Valued workforce able to inform trial design and demonstrate high quality trial conduct including effective collaboration; (positively impacts recruitment and retention, business)  

Key Accountabilities

•    Develop and implement systems, processes and infrastructure required for the continued development of NCTU and its portfolio, ensuring these are in line with changes in legislation and regulatory requirements and other developments

•    Lead on financial planning to adapt, develop and implement a business model for growth and financial stability in a fully cost-recovered model in the first instance (ultimately cost generating)

•    Oversee and co-ordinate decisions regarding agreement to collaborate, resource allocation and expertise in the development of grant applications including ensuring the use of a transparent costing framework for the unit

•    Oversee the delivery of NCTU’s portfolio, supporting Trial Managers, Data Managers, Clinical Trial Administrators, Clinical Data Systems and Statistical staff to ensure the trials are run efficiently, conforming to all applicable regulatory and ethical standards

•    Provide effective leadership and management of colleagues within NCTU, ensuring continuous professional development and implementing and monitoring a staff development training programme to ensure consistency in trial delivery and effective collaboration

•    Develop strong and effective working links between NCTU and associated groups within the Faculty, clinical collaborators, Sponsor organisations, RSS, other relevant external organisations, including other trials units and UKCRC

•    Promote a culture of organisational learning

The Person

Knowledge and Experience 

•    Senior business and research management expertise
•    Substantial knowledge of the research governance, regulatory and legislative framework for conducting clinical research trials and studies, including Good Clinical Practice

•    Clinical research management and operations at senior level including experience in the planning, coordination and conduct of clinical trials or studies

•    Effective financial management of large budgets, including planning, forecasting and resource allocation

•    Proven leadership skills in a multi-stakeholder environment

•    Knowledge of current national systems and structures for the funding and support of clinical research in the NHS

•    Experience of formulating and delivering strategy and associated resource planning

•    Extensive experience of leading, managing and working in teams, with excellent teamwork skills

•    Experience in change management and process improvement

•    Able to work independently, and to make decisions on complex matters

Skills and Behaviour

•    Excellent communication, interpersonal and negotiating skills to work with clinical, scientific and administration / management colleagues at all levels across a range of organisations

•    Ability to assess complex situations from a strategic perspective, considering both short and long term implications of any action

•    Able to work consultatively to find solutions
•    Ability to analyse, interpret, apply, and communicate highly complex or sensitive information
•    Ability to plan, manage, adjust, and deliver complex projects, involving multiple agencies and individuals and a broad range of activities to tight deadlines

•    Flexibility and pragmatism and the ability to deal with ambiguity

•    Ability to coach, manage and develop colleagues’ skills

Qualifications

•    Relevant post-graduate education, professional qualification or demonstrable equivalent experience plus substantial relevant managerial experience such as leading or managing an academic service/ support function or operating at a senior administrative level

Newcastle University is a global University where everyone is treated with dignity and respect.  As a University of Sanctuary, we aim to provide a welcoming place of safety for all, offering opportunities to people fleeing violence and persecution.

We are committed to being a fully inclusive university which actively recruits, supports and retains colleagues from all sectors of society.  We value diversity as well as celebrate, support and thrive on the contributions of all of our employees and the communities they represent.  We are proud to be an equal opportunities employer and encourage applications from individuals who can complement our existing teams, we believe that success is built on having teams whose backgrounds and experiences reflect the diversity of our university and student population.

At Newcastle University we hold a silver Athena Swan award in recognition of our good employment practices for the advancement of gender equality.  We also hold a Race Equality Charter Bronze award in recognition of our work towards tackling race inequality in higher education REC.  We are a Disability Confident employer and will offer an interview to disabled applicants who meet the essential criteria for the role as part of the offer and interview scheme.

In addition, we are a member of the Euraxess initiative supporting researchers in Europe. 

Requisition ID: 27925