Senior Trial Manager

We are a world class research-intensive university. We deliver teaching and learning of the highest quality. We play a leading role in economic, social and cultural development of the North East of England. Attracting and retaining high-calibre people is fundamental to our continued success.

We understand how important the full employment package is to our colleagues at Newcastle University and we are committed to providing a great range of benefits and discounts for all.  You can learn more about what is available here on our Benefits Website page.

Salary: £43,414 - £46,047, with progression to £51,805 per annum

Closing Date: 22 March 2023

The Role
 
Newcastle Clinical Trials Unit (NCTU) is a thriving registered academic unit, working in collaboration with investigators to design and deliver clinical trials answering important clinical questions, whose findings bring substantial impact to patients and the NHS.  We are delighted to share with you an exciting opportunity for Senior Trial Managers within our successful and expanding UKCRC Registered Clinical Trials Unit.

We currently have approximately 40 active trials and studies, and work with multiple trial sponsors locally, nationally and internationally from two hubs in Newcastle (main hub) and South Tees. Chief Investigators, Principal Investigators and Co-Investigators are located throughout and beyond the University. You may be expected to work at both sites depending on the needs of individual trials and NCTU. It is likely that you will be working on a portfolio of between 4 and 5 trials at any one time, though this will vary. The trials will be of varying types of design and intervention and may be single or multi-centre. NCTU is committed to the ongoing training and development of all colleagues, opportunities include a range of internal and external courses in clinical trials and information governance, as well as development and input through our UKCRC Registration, The UK Trial Manager Network and Trial Forge.   
 
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You will lead the trial design, co-ordination and delivery of trials, ensuring they are conducted in line with sponsor, regulatory and research governance requirements and directly manage Trial Managers and other NCTU colleagues. You will work as part of a multidisciplinary team and have the opportunity to work with other key stakeholders in the university.
 
We are looking for people who are enthusiastic and motivated, with excellent negotiating, communication and interpersonal skills.  
 
The role is full time, but we are keen to hear from people who may wish to discuss flexible working arrangements. We can offer a blended approach to home and office working.

If this is you, please contact Chrissie Butcher at chrissie.butcher@newcastle.ac.uk or Michelle Bardgett at michelle.bardgett@newcastle.ac.uk

Key Accountabilities

•    Provide leadership in clinical trial management to enable effective development and delivery of a portfolio of clinical questions to be answered robustly 
•    Demonstrate in-depth knowledge of individual trials, alongside knowledge of the relevant therapeutic area
•    Work with all members of the trial team (including the Chief Investigator, Trial Manager, Data Manager and Statistician) to identify and mitigate risk, agreeing trial timelines and milestones and ensure all processes throughout the trial lifecycle are completed within these, and subsequently agreed, plans
•    Work with the CTU team to ensure timely data cleaning procedures, and quality controls that produce trial data which are accurate, complete and timely
•    Proactively identify any issues within individual trials, appropriately escalating these and finding and implementing solutions (including: recruitment; protocol deviations; serious breaches)
•    Contribute to the costing and management of trial finances; forecasting needs for individual trials; liaising with the NCTU core business team to enable appropriate funding, and financial transactions and reporting in line with the contract
•    Manage the relationship with the Sponsor and Funder to ensure compliance with reporting requirements
•    Work with the grants and contracts team, Sponsor, Trial Manager and others, as appropriate, to ensure that contracts and agreements are in place for individual trials
•    Work as part of the Senior Trial Manager team and with others in NCTU (including QA) to ensure common ways of working and best practice in clinical trial management
•    Take responsibility for collating and reporting management information on clinical trial activities and outcomes, specifically overseeing the governance and reporting structures of trials and ensuring the required data are available for real time tracking of individual trial status
•    Develop, line-manage, support and advise a team of Trial Managers to ensure trials are developed, coordinated and managed effectively and conducted to required standards, including serious adverse event reporting.  This will include being responsible for training, development and PDR of these staff in accordance with NCTU central processes
•    Advise and manager the wider clinical trial team and associated stakeholders, and committees to ensure efficient operation and delivery
•    Contribute to the development of funding applications, advising on trial design; regulations; monitoring requirements; drug packaging and storage; procurement of other trial supplies and materials; liaison with UK Clinical Research Networks and consumer groups; and other aspects of trial feasibility including recruitment strategies
•    Oversee close down activities including contributing to the funder report and wider dissemination of trial findings
•    Ensure studies are conducted in accordance with GCP and other applicable legislation for Clinical Trials and the General Data Protection Regulation
•    Ensure good working relationships between NCTU and its clinical, academic and other partners and collaborators
•    Contribute to, lead on, writing and reviewing of SOP’s and policy documents on clinical trial management systems and processes in collaboration with the QA Team, including the review of quality improvement and other related initiatives
•    Contribute to internal NCTU staff training relating to clinical trial management
•    Contribute to formal and on-the-job training and development on trial related activities
•    Take responsibility for identifying own learning needs, including participating in regular Personal Development Review meetings
•    Advise on new collaborations, costing and pricing of trial proposals, and advise on staff capacity development and recruitment needs
•    Have extensive contact with internal and external personnel, including other Universities, NHS Trusts and funding bodies
•    Represent the Unit at internal and external meetings, creating and building on existing links
•    Support the management of change within NCTU
 
The Person 

 Knowledge, Skills and Experience 
•    Experience managing clinical trials through all stages, from start to completion
•    Sound knowledge of the principles of Good Clinical Practice, EU Clinical Trials Directive and the UK Policy Framework for Health & Social Care Research
•    Experience of making applications to external regulatory bodies
•    Effective report-writing and presentation skills with strong attention to detail
•    Demonstrable experience of chairing meetings with excellent oral and written communication skills
•    Ability to effectively inform workforce planning and develop colleagues to deliver success 

Attributes and Behaviour
•    Excellent interpersonal skills
•    The ability to make independent decisions without reference to others in areas of responsibility, as well as effective teamworking
•    Be able to plan and organise both own workload as well as supervise that of others
•    Enthusiastic, innovative approach to challenges
•    Ability to work to deadlines, organise own workload and work independently
•    Demonstrated commitment to ongoing personal development and training
•    Desire to share good practice

Qualifications
•    1st Degree (or equivalent professional qualification) in a relevant discipline
•    Formal training in Good Clinical Practice

Newcastle University is committed to being a fully inclusive Global 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 our employees and the communities they represent.  We are proud to be an equal opportunities employer and encourage applications from everybody, regardless of race, sex, ethnicity, religion, nationality, sexual orientation, age, disability, gender identity, marital status/civil partnership, pregnancy and maternity, as well as being open to flexible working practices.

The University holds a silver Athena SWAN award in recognition of our good employment practices for the advancement of gender equality. The University also holds the HR Excellence in Research award for our work to support the career development of our researchers, and is a member of the Euraxess initiative supporting researchers in Europe.

Requisition ID: 19106