Trial Management Team Leader - Cancer Research Clinical Trials Unit - 98944 - Grade 8

Position Details

Cancer Research Clinical Trials Unit, College of Medical and Dental Sciences

Location: University of Birmingham, Edgbaston, Birmingham UK

Full time starting salary is normally in the range £42,149 to £50,296. With potential progression once in post to £56,587 a year.

Grade 8

Full Time / Fixed Term Contract for up to 3 years. Hybrid working is possible in line with both CRCTU and University of Birmingham policies.

Closing date 8 February 2022

Job summary

The role of the post is to lead a team of trial management staff responsible for administration of a portfolio of clinical trial research projects. The Team Leader will assist the Trials Unit Directors in developing and maintaining the trials portfolio, promoting the CRCTU’s activities at a (inter)national level. They will oversee the administration of their clinical trials portfolio from concept to completion, taking an active role in providing specialist trial management advice, contributing to the design and costing of new trial proposals, preparing grant applications, coordinating trials (when necessary) and contributing to the presentation and publication of results. They will be responsible for ensuring that the team’s portfolio of trials is conducted according to applicable regulations and quality standards. They will be responsible for all aspects of staff management and will plan and monitor team finance and staff resource. They will contribute to the operation of the CRCTU by representing the team on the Operational Management Committee and take an active role in developing the CRCTU’s quality management system.

Main Duties/Responsibilities

• Lead a trial management team responsible for a portfolio of clinical trial research protocols (mainly in cancer) plus any other projects that may be allocated to the team from time to time.

• Report directly to the CRCTU Director of Operations and liaise with the relevant CRCTU (deputy) Director(s).

• Work largely independently but seek appropriate guidance on important or new issues that require an overview or policy decision or have serious resource implications, or could impact on the work of other teams or affect the unit’s external profile.

• Develop the team’s research portfolio. Provide specialist trial management advice to investigators. Take an active role in the development of new research proposals (including contributing to the design, preparation of grant applications and protocols), negotiate with external parties and assist in the preparation and review of contracts/agreements in liaison with the University of Birmingham Research Governance and Research Contracts Teams. 

• Prioritise research projects in liaison with the CRCTU (Deputy) Director(s) and allocate resource. Ensure milestones are met and projects are where possible delivered to time and target. Advise the CRCTU Director of Operations of potential issues which may affect delivery of the research portfolio and advise on and implement corrective action plan. 

• Manage the team’s portfolio ensuring that the research is performed in accordance with the applicable (inter)national regulations and quality standards, University of Birmingham and CRCTU procedures and external contracts/agreements. 

• Maintain oversight of the team’s work. Supervise the management of projects delegated to the team’s (Senior) Trial Coordinators, providing instruction, advice and guidance as necessary and providing innovative solutions to problems as appropriate. Review and sign off trial documentation. Where appropriate act as a member of the Trial Management Group. Monitor progress of the research projects keeping records of and dealing with any issues. Liaise with funders, external service providers and other third party organizations as appropriate.

• Where necessary to the successful delivery of the portfolio take on the responsibility for the coordination of selected trials (for example projects of high importance, complexity and sensitivity that require specialist knowledge or expertise 

• Responsible for the motivation of staff and for overseeing their line management, taking an active role in first line management and supervision when required. Responsible for the appointment of trial management staff, including drafting job descriptions and taking part in the selection processes. Ensure staff are appropriately trained to undertake their duties; including providing mentorship, coaching, one-to-one training, tutorials, setting, overseeing and signing off training plans. Oversee performance of staff development reviews. Provide advice and guidance to Senior Trial Coordinators and Trial Coordinators undertaking line management and supervisory duties respectively.

• Be involved in planning the financial aspects of new studies, negotiate budgets and access to services both internally and externally (i.e. with Industry and other sponsors; with other departments within the University and NHS Trust). Be responsible for monitoring and authorisation of expenditure and resource use against budgets on behalf of investigators, reporting via the CRCTU Director of Operations to the Divisional Manager. 

• Represent the CRCTU at (inter)national meetings. Contributing to working parties/committees at a local and (inter)national level including acting as members of University of Birmingham clinical trials committees/groups. Contribute to local and (inter)national trial management initiatives.

• Act as a member of the CRCTU Operational Management Committee, providing trial oversight, report progress, issues or potential problems to the CRCTU Director of Operations. Communicate policy and decisions positively to staff. Assist and on occasion take a lead on the preparation of unit reports.

• Actively contribute to the CRCTUs quality management system. Develop expert knowledge in areas of clinical trial management. Write policies, standard operating procedures and quality control documents. Take an active role in training staff. Positively promote the quality management system and ensure team compliance.

• Keep up to date with changes in trial methodology, relevant disease site literature, and regulatory issues and develop strategies for future direction of trial management. Help ensure that new skills, knowledge and best practice are disseminated widely and taken up by the CRCTU. 

• Contribute to the fundraising, teaching and educational aspects of the units work. 

• Undertake other task as applicable to the role and grade of the post. 

• Support the delivery of clinical research in accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, applicable legislation (including, but not limited to, the Medicines for Human Use Clinical Trials Regulations, Data Protection Act 1998, Human Tissue Act), the Research Governance Framework for Health and Social Care, Caldicott principals, and applicable NHS Trust and University policies and procedures, (including, but not limited to the University’s Data Protection Policy, Information Security Policy and Code of Practice for Research) in order to protect the research subject and the quality of each study.

• Actively manages equality, diversity and inclusion through monitoring and evaluation and actively challenging unacceptable behaviour

Person Specification

• A higher degree (in a relevant biomedical or associated subject) with strong experience of working in academic clinical trial management undertaking sponsor related duties, including experience of managing Investigational Medicinal Product clinical trials OR a graduate with extensive experience in clinical trial management as described above. 

• An in-depth understanding of clinical trial research, the regulations and guidance governing clinical trials in the UK and trial management methodology. 

• Proven ability to coordinate academic clinical trials, preferably covering all steps from design to publication. Experience of writing trial documentation (e.g. protocols and Case Report Forms) and reports, and data management essential. Experience of writing grants and contributing to trial design desired. Ability to define policy and procedure.

• Proven administrative and project management skills. 

• Proven ability to supervise, mentor, train and manage staff; including recruitment and appraisals. 

• Office management skills that include excellent word-processing, utilization and querying of clinical trial databases, and budget control. 

• Able to work on own initiative and problem solve while constantly prioritising work of self and others. Proven ability to multitask.

• Excellent communication, negotiation, presentation and inter-personal skills.

• Must demonstrate a critical and intelligent attention to detail and high standards of accuracy.

• Ability to meet the travel needs of the post nationally and internationally on occasion.

• Experience of championing Equality, Diversity and Inclusion in own work area. 

• Ability to monitor and evaluate the extent to which equality and diversity legislation, policies, procedures are applied. 

• Ability to identify issues with the potential to impact on protected groups and take appropriate action.

Further particulars can be found here: http://www.download.bham.ac.uk/vacancies/jd/MDSFPs.pdf

Informal enquiries can be made to Sarah Bowden ([email protected]) 

Valuing excellence, sustaining investment

We value diversity and inclusion at the University of Birmingham and welcome applications from all sections of the community and are open to discussions around all forms of flexible working