Clinical Trials Manager

Job Title: Clinical Trials Manager

Location: London

Contract: 5 months

Hours: 14.5 hours per week (9-5 Mondays/Tuesday)

Rates: £ 22.79-23.97 p/h

Job Description

SRG are looking for a clinical trials manager to join a leading higher educations provider based in London. The primary role of the post holder is to set up and support a high quality clinical trial at the CCTU.

Duties and Responsibilities

To establish and maintain effective management systems for the trial
To act as the central Trials Unit contact for the Trial
To work closely with the Chief Investigator, trial and IT staff to ensure the successful management of the Trial.
Secure all necessary approvals for the trial and participating sites according to the UK regulations including UK Research Governance Framework
Coordinate the design, printing and distribution of trial documentation
Develop trial specific documentation that is compliant with the CCTU Policies and Standard Operating Procedures (SOPs) and ensure this is implemented and kept up to date.
Ensure sites have appropriate training and maintain necessary records.
Work within budget constraints in liaison with the Project Manager.
Ensure that good communication is maintained between the CCTU and recruiting centre staff
Provide updates on the progress of the trial at regular Trial Management Group meetings, to the Independent Data Monitoring and Trial Steering Committees and to the funder as required.
Monitor the trial sites to assess compliance with the protocol and regulatory requirements.
Prepare under the guidance of the Clinical Project Manager, the trial specifications for the Database.
Undertake Risk Assessment of the trial and, with the Clinical Project Manager, propose appropriate mitigations.
Minute trial related meetings.
Supervise the data collected and enter data if required.
Supervise the data cleaning and validation, including querying and chasing missing data in a timely manner.
Monitor trial recruitment, providing support and motivation to recruiting staff as required.
Ensure the timely submission and processing of data and documents from sites to the CTU including safety events. Prepare and submit the necessary reports to appropriate regulatory, ethical and other parties (such as submission of safety reports to the Ethics Committee).
Represent the trial at conferences, meetings and internal unit meetings as appropriate.
Keep the relevant literature searches up to date.
Participate in university and the CCTU training and development initiatives.
Carry out any other comparable tasks as required including being prepared to assist those working on other studies/trials as directed by the Head of Clinical Trial Operations.Experience and Qualifications

Degree and/or equivalent experience in Clinical Trials
Experience of managing a clinical trial
Experience of managing a trial of an investigational medicinal product
Comprehensive understanding of UK Clinical Trials Regulations, ICH Good Clinical Practice, the European Directives on Clinical Trials and Good Clinical Practice and the Department of Health's Research Governance Framework
Experience of monitoring
Experience of using Pharmacovigilance systems
Experience of working in an academic or similar institution
Experience of public speaking and giving presentations
Experience of data management
Evidence of ability to set up and maintain effective management system in trials
Excellent IT skills; MS Office Suite, Trial Databases and other Trial related systems (such as IMP management, Randomisation)
Excellent communication and interpersonal skills
A methodical and accurate approach to work with attention to detail
The ability to make and carry out decisions and know when to confer with colleagues or refer matters onwards
The ability to work without direct supervision; to manage own workload and display good organisational ability
Take responsibility for setting and meeting targets for your own work and others
Ability to evaluate risks inherent in clinical trials and decide those which should be prioritised to ensure that risks are properly managed
Advanced organisational skills, managing several projects that are often time pressured, concurrently
Ability to supervise other members of the team, promote good working relationships and resolve difficult situations
Commitment to and knowledge of advancing equality, diversity and inclusionCarbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy