JOB DESCRIPTION. Position Number various. Job Title Trial Manager. Academic / Service Unit Newcastle Clinical Trials Unit. Effective Date

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1 Job Title Trial Manager Academic / Service Unit Newcastle Clinical Trials Unit Position Number various Effective Date Faculty / Central Services Faculty of Medical Sciences Grade F Vacancy Ref A118776A (CTU) Main Purpose The post is within the UK CRC registered Newcastle Clinical Trials Unit (NCTU). This is a multifaceted post requiring the post holder to set-up, manage, co-ordinate and support clinical trials to ensure that they are conducted in line with sponsor, regulatory and research governance requirements. The post holder will work as part of a multidisciplinary team including Senior 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. Main Duties and Responsibilities 1. Working as part of a trial team, provide day to day management of clinical trials undertaken by Newcastle Clinical Trials Unit; 2. Provide advice to investigators and trial staff to ensure compliance with legislative frameworks; 3. Demonstrate in-depth knowledge of individual trials, alongside knowledge of the relevant therapeutic area; 4. Work with all members of the trial team (including the Chief Investigator, Senior Trial Manager, Data Manager and Statistician) to ensure all processes throughout the trial lifecycle are completed within agreed trial time-lines, and any subsequently agreed plans; 5. Work with the Data Management team to ensure timely data cleaning procedures, and quality controls that produce trial data which are accurate, complete and timely 6. Proactively identify any issues within individual trials, appropriately escalating these, including to Senior Trial Managers, finding and implementing solutions as required (including: recruitment; protocol deviations; serious breaches); 7. Set-up clinical trials, undertaken by NCTU, including contributing to the development of the trial protocol and other trial documentation, required for compliance with legislative frameworks; 8. Complete and manage applications for Clinical Trials Authorisation, Ethical Opinion, HRA approval, and other approvals as required; 9. Work with the grants and contracts team, Sponsor, Senior Trial Manager and others, as appropriate, to ensure that contracts and agreements are in place for individual trials; 10. Perform site initiation visits and train site personnel in trial protocols and procedures during the trial; 11. Monitor clinical trials at trial sites, including measuring adherence to the protocol and standard operating procedures, and applicable regulatory requirements; 12. Close the trial, including completion of applicable regulatory reporting requirements, and contribute to the funder report and wider dissemination of trial findings; 13. Work as part of the Trial Manager team and with others in NCTU (including QA) to ensure common ways of working and best practice in clinical trial management; 14. Inform the development and implement the Unit s Standard Operating Procedures (SOPs) and develop trial-specific SOPs;

2 15. Prepare routine progress reports and ad hoc reports to funding bodies, sponsors, regulatory authorities, research ethics committees, Trust R&D departments etc; 16. Coordinate Trial Steering Committee, Data Monitoring and Ethics Committee, and Trial Management Group (TMG) meetings; 17. Chair TMG meetings and associated trial meetings; 18. Take responsibility for identifying own learning needs, including participating in regular Personal Development Review meetings with a Senior Trial Manager 19. Undertake other reasonable duties or responsibilities appropriate to the grade as requested from time to time by NCTU; 20. Ensure good working relationships between NCTU and its clinical, academic and other partners and collaborators. Dimensions There are currently approximately 50 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. The post holder will be expected to work at both sites depending on the needs of individual trials and NCTU. It is likely that the post-holder will be working on a portfolio of between 2 and 4 trials at any one time, though this will vary. The trials will be of varying types of intervention and may be single or multi centre. There will be opportunity to input academically and operationally to trial development, and to have this recognised in publications. Planning and Organising The post-holder will be able to plan and organise their own workload Decision Making The post-holder will be required to make independent decisions and to advise and work with others on the trial. You will take responsibility for identifying your own learning needs, including participating in regular Personal Development Review meetings with a Senior Trial Manager to set development goals and objectives and chart progress in relation to these. Internal and External Relationships The post-holder will: liaise with external organisations regularly including NHS Trusts, Universities, funding bodies and UK CRC registered Trial Unit working groups develop close and effective working relationships with PIs, CIs, CTU, NIHR RDS & other colleagues and representative of study sponsors to ensure compliance and provide support in this area represent the unit at external events as appropriate Other Relevant Information It is expected that Trial Managers will be trained and experienced in Good Clinical Practice and Ethical Guidelines; have excellent communication skills, excellent organisational and administrative skills; communicate well orally and in writing producing high quality documents and reports. You will be expected to appropriately handle confidential and sensitive information.

3 Organisation Chart Newcastle Clinical Trials Unit Person Specification Knowledge (inc. qualifications) 1st degree (or equivalent professional qualification and/or experience) in a relevant discipline Formal training in Good Clinical Practice Desirable Higher degree in a relevant discipline Experience and Achievements (paid or unpaid) Understand the principles of management of clinical trials, including the role of a trial manager in the lifecycle of a trial Knowledge of the provisions of the EU Clinical Trials Directive and the UK Policy Framework for Health and Social Care Research A sound knowledge of the principles of Good Clinical Practice

4 An understanding of the process for making applications to regulatory bodies (MHRA) and to ethical committees via IRAS Good working knowledge of MS Office applications Experience of project planning and management Desirable Experience in the management of clinical trials, at sponsor / project management level Experience of performing Site Initiation Visits Experience of central and site-based monitoring Experience of making applications to regulatory bodies (MHRA) and to ethical committees via IRAS Experience of Chairing meetings Skills, Abilities and Personal Qualities Excellent interpersonal, oral and written communication skills Effective report writing and presentation skills Ability to work independently, alongside excellent team-working skills Enthusiastic, innovative and proactive approach to work; able to think critically and have the ability to rapidly assess and link information Ability to work to deadlines, and organise own workload Demonstrated commitment to ongoing personal development and training Attention to detail Other Flexibility with respect to working hours Willingness to travel outside of the Newcastle and South Tees areas

5 Behaviours (Success Factors) Name Taking responsibility Working Together Looking to the Future Inspiring Others Typical Behavioural Indicators Planning and Organising Manages time and resources by prioritising and organising effectively. Works in a planned and structured way Plans workload and tasks in a systematic way Sets own priorities in conjunction with team objectives Team Working Works collaboratively with others, plays a positive role in teams and establishes and grows relationships across the organisation where different skills, expertise and opinions are valued. Shares relevant and useful information Willing to help others and share workloads Respects the value that different views bring to the team Gathering Information Gathers a broad range of relevant information from internal and external sources making this information widely available. Gathers relevant information and facts Is thorough in investigating an issue: no stone left unturned approach. Has an eye for detail, spotting errors and ensuring accurate information Communicating Uses clear, concise and accurate communication, tailoring the approach accordingly and encouraging a two way communication process. Is factually correct and gives consistent verbal and non-verbal messages Clear and concise: gets the message across to others Chooses communication tools appropriately e.g. selective use of s and other channels of communication For full details about this vacancy and essential information on how to apply, visit our Job Vacancies web page at