Head of Operations - Clinical Trials Unit

Salary: £56,021 to £59,421, with progression to £64,914 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: 09 June 2024

The Role

This is an exciting opportunity to join Newcastle Clinical Trials Unit (NCTU), a UK Clinical Research Collaboration (UKCRC) registered Clinical Trials Unit, as Head of Operations. 

NCTU is an academic unit, that works in collaboration with investigators to design and conduct high quality trials and studies, bringing substantial impact to patients and society. Our growing reputation for innovative trial design is evident in our portfolio https://www.ncl.ac.uk/nctu/ As a new strategic appointment, you will take a leadership role in the further development of NCTU. You will work with the Director, Deputy Director and Clinical Deputy Director in the development and implementation of strategy, building on the strengths of the diverse portfolio, aligning with Newcastle University strategy and responding to national research priorities.

You will develop the operational structures and processes needed to implement NCTU’s strategic plan and drive excellence in the delivery of the portfolio, in the development of people, and in the collaborative experience of investigators working with NCTU. You will lead in matters of research governance, adherence to regulatory requirements, quality assurance, resource and financial management.

You will report to the Director of NCTU, the Deputy Director, and Clinical Deputy Director, as part of the Senior Leadership Team. You will interact with the Head of Faculty Operations and the Chief Operating Officer for the NIHR Research Support Service (RSS). You will join a team of nearly 70 staff, of which the senior team (senior trial managers, senior data manager and quality assurance manager) will be direct reports. You will work closely with the Biostatistics Research Group, a team of 30 statisticians.

This is a full time fixed term role, available until 30 September 2028

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

You will:
Develop and implement systems, processes and infrastructure required for the continued development of NCTU and its portfolio, responding to changes in legislation and regulatory requirements and other developments.
Provide effective leadership and management of colleagues within NCTU, ensuring continuous professional development and establishing and maintaining an effective, collaborative, team-based working environment.

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.
Provide senior business and research management expertise to drive NCTU’s strategy and business and financial planning processes. 
Promote and create a culture of organisational learning which encourages individual and unit growth.

If you want to find out more about this role please contact Liz Wood.

Key Accountabilities
Strategy
•    Work closely with the Directors in the development and implementation of NCTU’s business plan and strategy
•    Take policy decisions relating to the Unit’s implementation of applicable legislation, UK Policy Framework for Health and social care research and University procedures
•    Attend and / or Chair, and contribute to, key committees and management groups including NCTU Senior Management team, NCTU Executive Advisory Board
•    Ensure Public Patient Involvement activities and the commitment to EDI across all NCTU activities in line with strategy

Research Portfolio
•    Take a lead role in developing new business and input into proposals
•    Provide oversight of the multidisciplinary teams responsible for robust delivery of NCTUs trial and study portfolio
•    Develop and implement robust processes to ensure NCTU can support a diverse range of trial designs and trial phases on the portfolio
•    Oversee and co-ordinate decisions regarding agreement to collaborate, resource allocation and expertise in the development of grant applications including use of a transparent costing framework for the unit
•    Oversee the negotiation of contracts for new UK, EU and international trials and research awards in collaboration with University Contract teams, Joint Research Office and Sponsors
•    Lead resource allocation, financial and contractual management for individual trials and studies and awards; this includes mapping current and monitoring future activity, needs and funding
•    Oversee the delivery of NCTU’s portfolio to ensure the trials are run efficiently and adhere to regulatory and ethical standards
•    Ensure integration of Statistics teams including around Clinical Data Systems and Quality Assurance

NCTU Team
•    Provide professional leadership to all staff, overseeing / undertaking ongoing management, development, training and mentoring of the team, including Senior Trial Managers and Senior Data Managers and QA Manager 
•    Oversee effective recruitment and induction of all staff 
•    Oversee provision of training and staff development to ensure all staff are appropriately qualified and trained to undertake their roles
•    Contribute to the development of local and national training programmes as required.  Oversee Unit staff workloads
•    Maintain an awareness of best practice with regard to managing and developing staff using appropriate team building and change management skills to ensure the cohesiveness, effectiveness and continuity of the unit
•    Evaluate facilities and management services provided for NCTU staff working both within the Trials Unit and externally around the country and overseas, and manage the implementation of possible improvements
•    Promote equality and diversity in working practices and maintain positive working relationships

Finance and Operational Management
•    Implement and operationalise the Unit’s strategy, developing the infrastructure and systems necessary for the smooth and efficient operational running of NCTU
•    Lead NCTU financial planning and ensuring, with the Directors, the Unit remains financially sound and capable of achieving its strategic objectives
•    Manage, monitor and report budgets, working closely with Joint Research Office, Faculty finance teams and external organisations responsible for financial reporting and meeting reporting deadlines as required
•    Work with colleagues in the Faculty, University, Nationally and Internationally in relation to the implementation of research governance requirements, compliance with clinical trial legislation, and best practice

Quality Assurance
•    Oversee the development and implementation of the Unit’s Quality management System (QMS) ensuring implementation of procedures that conform to the delivery of research in accordance with Good Clinical Practice and applicable legislation, working closely with the Quality Assurance team
•    Oversee the planning and conduct of trial and systems audit activity
•    Provide support, and lead where necessary, on the escalation of trial related issues to Sponsor / the regulator
•    Oversee the preparation and conduct for any (MHRA) GCP inspection or 3rd party audit 

Communication and Relationships
•    Develop and deliver an effective communication and information management plan within and external to NCTU
•    Represent NCTU’s interests at local, regional and national level including as a member of UKCRC groups and committees
•    Establish and maintain effective working relationships with all relevant organisations and stakeholders

The Person

Knowledge, Skills and Experience 
•    Working 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
•    Knowledge of current national systems and structures for the funding and support of clinical research in the NHS
•    Proven leadership skills in a multi-stakeholder environment
•    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
•    Effective financial management of large budgets, including planning, forecasting and resource allocation
•    Able to work independently, and to make decisions on complex matters

Desirable
•    Experience of working in research in social care or in public health 
•    Practical experience of working in clinical trials

Attributes and Behaviour
•    Demonstrate strong communication and interpersonal skills whether that be describing the vision, engaging and leading people or influencing our stakeholders
•    Able to think strategically and to analyse, interpret, apply and communicate highly complex or sensitive information, including where there are conflicting priorities
•    Ability to plan, manage, adjust and deliver complex projects, involving multiple agencies 
    and individuals and a broad range of activities to tight deadlines

Qualifications
•    Educated to degree level or evidence of equivalent experience

Desirable
•    Post-graduate degree in a relevant subject or professional qualification

To view the Candidate Information Pack please click here

 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: 26472

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