Senior Trial Manager

Salary: £45,585 to £48,350 with progression to £54,395 per annumNewcastle University is a great place to work, with excellent . 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: 23 April 2024The RoleThe post is based within the UKCRC registered Newcastle Clinical Trials Unit (NCTU).You will work as part of a team of Senior Trial Managers to provide comprehensive management to a portfolio of clinical trials run in collaboration with NCTU. You will understand and contribute to the scientific, design, regulatory and technical elements of clinical trials; you will provide advice to ensure they are designed, delivered and managed efficiently, in line with sponsor, regulatory and research governance requirements. You will be expected to appropriately handle confidential and sensitive information. The Senior Trial Manager will directly manager one or more Trial Managers and other NCTU staff as appropriate. NCTU’s portfolio includes clinical trials across all phases, in support of NCTU strategic aims.There are currently approximately 40 active trials being conducted by NCTU. NCTU works with multiple trial sponsors, locally, nationally and internationally and from two main hubs in Newcastle and South Tees. Chief Investigators, Principal Investigators, and Co-Investigators are located throughout and beyond the University, including nationally and internationally. You will work at both sites depending on the needs of individual trials and NCTU.You will report to the NCTU Senior Leadership Team and work closely with Trial Managers, Data Managers, Investigators, Collaborators, Sponsors and the wider research team to deliver trials including monitoring of and progress against milestone targets, highlighting and managing risks as appropriate.This post is full-time and open-ended.Further information can be obtained by contacting orFind out more about the Faculty of Medical Sciences here:Find out more about our Research Institutes here:As part of our commitment to career development for research colleagues, the University has developed 3 levels of . These profiles set out firstly the generic competences and responsibilities expected of role holders at each level and secondly the general qualifications and experiences needed for entry at a particular level.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
• To 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
• To 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
• To 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
• You will 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
• Undertake other duties, appropriate to the grade, which may be required from time to time by NCTU

The PersonKnowledge, Skills and Experience

• Significant experience in the management of clinical trials, at sponsor/project management level
• In-depth knowledge of the provisions of the EU Clinical Trials Directive and the UK Policy Framework for Health & Social Care Research
• A sound knowledge of the principles of Good Clinical Practice
• Experience of making applications to regulatory bodies (MHRA) and to ethical committees via IRAS
• Experience of managing and developing staff
• Experience of Chairing meetings
• Good working knowledge of MS Office applications
• Effective report-writing and presentation skills
• Excellent oral and written communication skills
• Attention to detail
• 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
• Be able to inform staffing requirements

Desirable

• Knowledge of clinical trial design
• Experience of costing of studies
• Experience of contributing to bid development
• Experience of using project management software or formal project management techniques
• Hands-on experience of central and site-based data monitoring

Attributes and Behaviour

• Excellent interpersonal skills
• 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 spread good practice
• Flexibility with respect to working hours
• Willingness to travel outside of the Newcastle and South Tees

Qualifications

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

Desirable

• Higher Degree in a relevant discipline

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 award in recognition of our good employment practices for the advancement of gender equality. We also hold a Bronze award in recognition of our work towards tackling race inequality in higher education REC. We are a 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: 26823