Senior Trial Manager (Part time) - Clinical Trails Unit

Location
United Kingdom
Salary
£30,395 - £42,036
Posted
Aug 15, 2019
Closes
Sep 14, 2019
Ref
117086
Organization Type
University and College
Hours
Part Time
Position Details

Birmingham Clinical Trails Unit

College of Medical and Dental Sciences

University of Birmingham, Edgbaston, Birmingham UK

Full time starting salary is normally in the range £30,395 to £39,609. With potential progression once in post to £42,036 a year.

Part time: 50%

Closing Date: 2 September 2019

Job Purpose

We are looking to recruit a Senior Trial Manager to join the Birmingham Clinical Trials Unit to support the clinical research being undertaken by the unit.

Main duties

Responsible for managing a portfolio of trials associated with a clinical speciality and the staff working on those trials in addition to actively coordinating trials. Contribute to the design, conduct, analysis, publication and presentation of clinical trials research.
  • Take a fundamental role in the design and preparation of new clinical trial research proposals and make a personal contribution to the Clinical Trial Unit's research activity and profile. This will include preparation of costings and grant applications; writing and editing the protocol, and design of case report forms and databases used to collect research data.
  • Keep up to date with current research literature and developments in the clinical speciality relevant to the portfolio of trials and the profession of clinical trial management. Maintain relevant bibliographies by regular literature searches and critical review. Bring ideas for innovative trials to the attention of the relevant clinical lead. Write literature reviews, develop and publish innovative approaches to improving trial methodology.
  • Prepare appropriate interim publications (e.g. meeting abstracts) to maintain the research profile of each trial, and play a pivotal role in the preparation and timely completion of final research publications.
  • Keep up to date with changes in trial methodology, regulatory issues and new legislation. Help develop strategies for their implementation at team level and also national level if appropriate to the trial. Help ensure that new skills, knowledge and best practice are disseminated internally and externally to study sites if appropriate. This will involve contributing to the quality assurance programme by writing/ approving / implementing Standard Operating Procedures for the trials unit.
  • Personally manage selected trials taking a lead in preparing and organising meetings, reports and other activities of high importance and/or complexity and/or sensitivity that require specialist knowledge or expertise. This will generally include setting-up new trials, negotiation with key external bodies, overseeing the setting-up and monitoring of clinical sites and ensuring trials are run in accordance with current legislation.
  • Take primary responsibility for ensuring that trial research data is complete and accurate. Work closely with members of the statistical team to validate the data set.
  • Responsible for management of junior staff with respect to day-to-day supervision, motivation and support of the staff including work allocation, cover rotas, problem solving, staff development and monitoring performance. Advise and assist in the appointment and training of the junior trial management staff. Mentor, coach, and guide other members of the team as necessary.
  • Obtain appropriate regulatory and ethical approval for individual clinical trials. Ensure the Standard Operating Procedures for the safe conduct of each trial are followed for example by reporting of adverse events to regulatory authorities and the Data Monitoring Committee.
  • Prepare trial progress reports as required by the regulatory authorities; ethics committees; Trial Steering and Data Monitoring Committees; funding bodies, and external collaborators.
  • Ensure a first point of contact is identified for day-to-day queries from study sites regarding compliance with each research protocol and provide cover for Trial Managers.
  • Promote the research portfolio of trials for the relevant clinical speciality by the preparation of newsletters, posters and by presenting at local, national and occasionally international scientific meetings.
  • Prepare Standard Operating Procedures for the running of individual clinical trials to ensure that the research complies with current legislation.
  • Initiate and oversee the design, coding and testing of the research databases.
  • Set up clinical sites, and ensure that participating staff at these sites understand and are able to comply with the trial protocol and Good Clinical Practice and ensure that appropriate audit trails are being maintained in line with current legislation.
  • Monitor progress of each centre and take appropriate action to ensure good recruitment, compliance with the protocol and the quality and timeliness of the data collection. Use initiative to tackle any practical difficulties reported by clinical sites which may affect recruitment, protocol adherence or patient safety. Conduct problem solving / quality assurance monitoring visits as required.
  • Interpret statistical data.
  • Act as a member of one or more trial management groups, responsible for the management and organisation of the conduct of clinical trial protocols and administration of the clinical collaborative groups.
  • Coordinate and support the activities of the Trial Management Group, Steering Committee, Data Monitoring Committee, and the larger collaborative group.
  • Plan expenditure against own trial budgets and negotiate with suppliers.
  • Organise and coordinate national meetings when required including preparation of an appropriate agenda, obtaining sponsorship etc.
  • Lecture on relevant courses and supervise students as required.
  • Make an active contribution to setting, maintaining and communicating Clinical Trial Unit policy, quality standards and trial management frameworks to junior members of staff.
  • 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, General Data Protection

Regulation (GDPR), Data Protection Act 2018, 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.

Person Specification
  • A higher degree (PhD or MSc) in a relevant biomedical science or associated subject with experience of clinical trials research (for some roles a proven track record of successfully obtaining research funding from a recognised funding body will suffice) or a graduate with strong experience as a Trial Coordinator and a proven ability to taken on a senior role.
  • The ideal candidate would have some experience of running trials in a surgical and/or international setting
  • The successful candidate may be required to travel internationally as part of the role
  • An in-depth understanding of clinical research and trial management methodology, including applicable regulatory requirements, and a proven ability to apply these to the coordination of clinical trials
  • Experience preparing regulatory and ethics submissions; grant applications; writing and/or amending protocols; patient information sheets; case report forms; reports, and other relevant clinical trial management documentation
  • Proven project management and supervisory skills.
  • Excellent administrative, clerical and office management skills.
  • Effective communication, negotiation, presentation and inter-personal skills.
  • Excellent computing skills including advanced word processing and email. Experience in the design, maintenance and interrogation of complex relational databases (MS Access preferred).
  • Able to work on own initiative and problem solve.
  • Must demonstrate a critical and intelligent attention to detail and high standards of accuracy.
  • Experience preparing publications and submitting grant applications.

For further information please contact Hayley Walton, h.l.walton@bham.ac.uk

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