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Senior Trial Manager - Birmingham Clinical Trials Unit

Employer
Global Academy Jobs
Location
United Kingdom
Salary
£30,395.00 - £39,609.00
Closing date
Oct 6, 2019

Job Details

The post holder will be responsible for applying specialist knowledge in the key areas of clinical trial start-up and close down. Lead on all start-up activities prior to first site activation and close down activities leading up to and following database lock, in collaboration with other teams within the Unit. Contribute to the design, conduct, analysis, publication and presentation of clinical trial research.

Main duties
  • Provide expertise in the start-up and close down phases of clinical trials. Apply specialist knowledge in these key areas and oversee and lead on all start-up activities prior to first site activation and close down activities leading up to and following database lock, in collaboration with other teams within the Unit. This will include negotiation with key external bodies, overseeing and monitoring of clinical trial sites during set-up and close down and ensuring trials adhere to current legislation.
  • Play a pivotal role in ensuring clinical trial timeframes are met with respect to adhering to both the funder and regulatory/ethical requirements. Drive efficiency and reduction of timelines. Work towards forecasted submission/approval timelines, track milestone progress and provide support on contingency plans to mitigate impact as required.
  • Lead on protocol, case report form and database development and obtain all appropriate regulatory and ethical approvals for individual clinical trials. Set up clinical trial sites, and ensure that participating staff at these sites are trained and are able to comply with the trial protocol and Good Clinical Practice and that appropriate audit trails are maintained in line with current legislation.
  • Monitor progress of clinical trial sites and take appropriate action to ensure sites are set up to be able to deliver on recruitment targets, compliance with the protocol and quality and timeliness of the data collection. Use initiative to tackle any practical difficulties reported by sites which may affect recruitment, protocol adherence or patient safety. Conduct problem solving / quality assurance monitoring visits as required.
  • At trial close down, lead on ensuring that all clinical trial related activities are appropriately reconciled, recorded, and reported at the end of a trial in accordance with the protocol, SOPs, GCP and the applicable regulatory requirements.
  • Lead on archiving activities related to the Trial Master File and support trial teams with regulatory requirements for end of trial reporting. Work with trial teams to ensure that trial research data are complete and accurate. Work closely with members of the statistical team, as required, to validate the data set
  • Keep up to date with changes in trial methodology, regulatory issues and new legislation. Help develop strategies for their implementation if appropriate. Help ensure that new skills, knowledge and best practice are disseminated internally and externally as appropriate. This will involve contributing to the quality assurance programme by writing/ approving / implementing Standard Operating Procedures for the trials unit.
  • As required, 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.
  • 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 staff as necessary. Ensure a first point of contact is identified for day-to-day queries and provide cover for Trial Managers.
  • Prepare trial progress reports, as required, by the regulatory authorities; ethics committees; Trial Steering and Data Monitoring Committees; funding bodies, and external collaborators.
  • Promote the research portfolio of trials for the relevant clinical specialty by the preparation of newsletters, posters and by presenting at local, national and occasionally international scientific meetings.
  • Prepare Standard Operating Procedures to ensure that the research complies with current legislation.
  • As required, initiate and oversee the design, coding and testing of the research databases.
  • As required, take a leading role in the design and preparation of new clinical trial research proposals
  • As required, prepare appropriate interim publications (e.g. meeting abstracts) to maintain the research profile, and contribute as required to the preparation and timely completion of final research publications.
  • 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 trial budgets and negotiate with suppliers.
  • Organise and coordinate national meetings when required including preparation of an appropriate agenda, obtaining sponsorship etc.
  • Keep up to date with current research literature and developments in the clinical speciality and the profession of clinical trial management. As required, 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.
  • Make an active contribution to setting, maintaining and communicating Clinical Trial Unit policy, quality standards and trial management frameworks to junior members of staff.
  • Promotes equality and values diversity acting as a role model and fostering an inclusive working culture.
  • 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.

Dimensions

Staffing
  • Senior Trial Managers act as first line managers to a small group of trial management staff including Trial Managers (academic-related grade 6), Senior Data Managers (Support Band 500) and/or Data Managers (Support Band 400). They report to the Trial Team Leader/Director of Operations

Financial
  • Senior Trial Managers assist academic investigators in the costing, preparation and submission of research grant applications, providing specialist trial management advice and working under the guidance of the Trial Team Leader/ Director of Operations. They may be named as co-applicants on grant applications in their own right.
  • Senior Trial Managers also monitor and approve expenditure on research grants, although the overall responsibility rests with the Trial Team Leader and the grant holder.

Customer
  • An important aspect of the post of Senior Trial Manager is to build relationships with a range of customers, typically including: professors, consultants, nurses, pharmacists and other medical professionals who may be members of one of the trial groups/committees or based at participating sites; other trials professionals e.g. statisticians, programmers, monitors; patients and patient representatives; the Sponsor representative; contracts officers, and suppliers.
  • Senior Trial Managers can personally manage clinical trials (i.e. act as the Trial Manager) as well as providing specialist advice and guidance on all clinical trials within a portfolio. As such they will come into contact with a large group of internal and external customers (>500).
  • Operational Clinical trials are highly regulated and Senior Trial Managers play a pivotal role in ensuring compliance of their portfolio of trials with the regulations governing clinical trials and the Clinical Trials Unit policies and procedures. Senior Trial Managers are expected to make an active contribution to the writing of, and training on, Standard Operating Procedures for specific trial management related tasks. They identify issues with operational procedures and are members of internal working groups to address operational issues. They are also expected to convey the Clinical Trials Unit policies and procedures to both internal and external investigators.
  • Senior Trial Managers represent the Clinical Trial Unit in a professional capacity at local, regional, national and international meetings and fund raising events.

Planning and organising
  • Senior Trial Managers may manage a small portfolio of research projects and/or clinical trials and the individuals working on those projects. They may personally coordinate trials or provide specialist knowledge in key areas.
  • Responsibility for a particular project and member(s) of staff will be allocated by the relevant Trial Team Leader. Trials are typically between 3 and 10 years duration. They follow a standard path through grant application, set-up, recruitment, follow up, analysis, closure and archiving, and the Senior Trial Manager's role will vary according to the composition of the portfolio and the stage of each of their trial(s).
  • Senior Trial Managers will need to plan and organise their own workload, and that of staff working on their portfolio of trials. The Senior Trial Manager will need to be reactive, as problems (e.g. safety issues) and queries from sites and/or patients often arise with very short notice and quite frequently have to be dealt with immediately. Hence, Senior Trial Managers have to be very organised and able to reprioritise their workload at short notice while still meeting regulatory deadlines.
  • Problem solving and decision making
  • Senior Trial Managers must be able to work independently and are expected to deal with most day-to-day problems for example problems regarding GCP compliance, non-clinical protocol queries and staffing issues without reference to others. They must be able to use sound judgment in deciding when queries need to be forwarded onto a clinician (for example safety or treatment queries) or a more senior member of staff (for example serious staffing problems, potential serious breach of the protocol or GCP).
  • They are expected to ensure staff follow the Clinical Trials Unit quality management system and comply with the protocol, the ethical and regulatory approvals for each trial, GCP, research governance guidelines and applicable regulations.
  • Internal and external relationships

Contact Purpose/skills required
  • Funding Bodies Must be able to effectively communicate details of each research proposal. Good negotiation skills are required.
  • Professors & Consultants Written and verbal communication and presentation skills must be excellent. Must be able to clearly explain the scientific background, and the clinical, practical and financial aspects of research projects.
  • Patients Must be able to communicate with patients, answering queries in a way appropriate to their level of understanding. Will take responsibility for writing Patient Information Sheets which must be easy for the layperson to understand and comply with current ethical guidelines.
  • Suppliers Be able to effectively negotiate with suppliers.

Person Specification
  • Hold, or be close to completion of, a higher degree in a relevant biomedical or associated subject with experience of clinical trials research, or a graduate with strong experience as a Trial Coordinator and a proven ability to take on a senior role.
  • In depth understanding of clinical research and trial management methodology, including 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, trial management forms, reports and other and documents.
  • Experience of using statistics packages to perform statistical tests to analyse and manage trial data.
  • Experience preparing publications and submitting grant applications is desirable.
  • Proven administrative, project management and supervisory skills
  • Ability to work on own initiative and problem solve
  • Excellent IT skills, including the design, maintenance and interrogation of complex relational databases.
  • Effective communication, negotiation, presentation and interpersonal skills
  • Critical and intelligent attention to detail and high standard of accuracy.
  • Ability to meet the travel needs of the post.
  • Knowledge of the protected characteristics of the Equality Act 2010 and understands how to ensure in day to day activity in own area that those with protected characteristics are treated equally and fairly.

For informal enquiries please contact Hayley Walton, h.l.walton@bham.ac.uk

This is a fixed term contract for up to 24 months

Closing Date: 4 August 2019

2 POSTS AVAILABLE

Company

Global Academy Jobs works with over 250 universities worldwide to promote academic mobility and international research collaboration. Global problems need international solutions. Our jobs board and emails reach the academics and researchers who can help.

"The globalisation of higher education continues apace, driving in turn the ongoing development of the global knowledge economy, striving for solutions to the world’s problems and educating a next generation of leaders and contributors."

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