The Role
Newcastle Clinical Trials Unit 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.
The Senior Trial Manager will lead the trial design, coordination and delivery of several trials, ensuring that they are conducted in line with sponsor, regulatory and research governance requirements. You will directly manage Trial Managers and other NCTU staff. You will work as part of a multidisciplinary team including Trial Managers, Clinical Trial Administrators, Statisticians, Data Managers, Chief Investigators and members of Trial Management Groups and other stakeholders to ensure successful completion of trials.
The post requires an enthusiastic and motivated individual, with excellent negotiating, communication and interpersonal skills. You will have a first degree in a relevant discipline, significant experience in the management of clinical trials and an in-depth knowledge of the provisions of the EU Clinical Trials Directive and the UK Policy Framework for Health and Social Care Research.
We work with multiple trial sponsors locally, nationally and internationally from our hub in Newcastle. Chief Investigators, Principal Investigators and Co-Investigators are located throughout and beyond the University. We operate a blended approach to home and office working in line with University Guidance. 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. Newcastle Clinical Trials Unit is committed to the ongoing training and development of all staff. Opportunities include a range of internal and external courses in clinical trials and information governance, as well as opportunities for development and input through our UKCRC Registration, The UK Trial Manager Network and Trial Forge.
Requests for part time working will be considered.
Informal enquiries may be made to: Chrissie Butcher () and Miranda Morton ()
Further information regarding Newcastle Clinical Trials Unit can be found via the following link:
Key Accountabilities
1. Provide leadership in clinical trial management to enable effective development and delivery of a portfolio of clinical questions to be answered robustly
2. Demonstrate in-depth knowledge of individual trials, alongside knowledge of the relevant therapeutic area
3. 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
4. Work with the CTU team to ensure timely data cleaning procedures, and quality controls that produce trial data which are accurate, complete and timely
5. Proactively identify any issues within individual trials, appropriately escalating these and finding and implementing solutions (including: recruitment; protocol deviations; serious breaches)
6. 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
7. Manage the relationship with the Sponsor and Funder to ensure compliance with reporting requirements
8. 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
9. 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
10. 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
11. 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.
12. Advise and manager the wider clinical trial team and associated stakeholders, and committees to ensure efficient operation and delivery
13. 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
14. Oversee close down activities including contributing to the funder report and wider dissemination of trial findings
15. Ensure studies are conducted in accordance with GCP and other applicable legislation for Clinical Trials and the General Data Protection Regulation.
16. Ensure good working relationships between NCTU and its clinical, academic and other partners and collaborators
17. 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
18. Contribute to internal NCTU staff training relating to clinical trial management
19. To contribute to formal and on-the-job training and development on trial related activities
20. Take responsibility for identifying own learning needs, including participating in regular Personal Development Review meetings
21. The post holder will advise on new collaborations, costing and pricing of trial proposals, and advise on staff capacity development and recruitment needs
22. Have extensive contact with internal and external personnel, including other Universities, NHS Trusts and funding bodies.
23. Represent the Unit at internal and external meetings, creating and building on existing links
24. Support the management of change within NCTU
25. Undertake other duties, appropriate to the grade, which may be required from time to time by NCTU.
The Person
Knowledge, Skills and Experience
Essential
26. Significant experience in the management of clinical trials, at sponsor/project management level
27. In-depth knowledge of the provisions of the EU Clinical Trials Directive and the UK Policy Framework for Health & Social Care Research
28. A sound knowledge of the principles of Good Clinical Practice
29. Experience of making applications to regulatory bodies (MHRA) and to ethical committees via IRAS
30. Experience of managing and developing staff
31. Experience of Chairing meetings
32. Good working knowledge of MS Office applications
33. Effective report-writing and presentation skills
34. Excellent oral and written communication skills
35. Attention to detail
36. The ability to make independent decisions without reference to others in areas of responsibility, as well as effective teamworking
37. Be able to plan and organise both own workload as well as supervise that of others
38. Be able to inform staffing requirements
Desirable
39. Knowledge of clinical trial design
40. Experience of costing of studies
41. Experience of contributing to bid development – a/a
42. Experience of using project management software or formal project management techniques – a/a
43. Hands-on experience of central and site-based data monitoring
Attributes and Behaviour
44. Excellent interpersonal skills
45. Enthusiastic, innovative approach to challenges
46. Ability to work to deadlines, organise own workload and work independently
47. Demonstrated commitment to ongoing personal development and training
48. Desire to spread good practice
49. Flexibility with respect to working hours
50. Willingness to travel outside of the Newcastle area
Qualifications
Essential
51. 1st Degree (or equivalent professional qualification) in a relevant discipline
52. Formal training in Good Clinical Practice
Desirable
53. 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 Gold 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: 29045
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