JOB DESCRIPTION
Job Title:
Clinical Trials Manager (SM197-14)
Department:
Surgery and Cancer
Unit/Section:
Imperial Clinical Trial Unit – Section on Cancer (ICTU-Ca)
Job Family/Level:
Professional Services, Level 4
Salary Range:
£43,530 - £52,630 per annum
Responsible to:
CRUK Centre Senior Clinical Trials Manager
Key relationships:
ICTU (SPH) Core ICTU staff including Operations Managers, QA Manager,
InForm and Communications Manager, Head of Clinical Trial Statistics,
Cancer Research UK, Institute of Cancer Research, Research and
Administrative colleagues of Division of Cancer, Joint Research Office, Joint
Research Compliance Office, ICHNT, Pharmaceutical Companies, Local
and National Research Networks, staff from other CTUs, Ethical and
Regulatory bodies
Contract:
Full time for a fixed-term of 1 year in the first instance
Location:
Charing Cross (Hammersmith) and Hammersmith (East Acton) campuses
Background:
The Cancer Section of the Imperial Clinical Trials Unit (ICTU-Ca) is based at Imperial College’s Charing
Cross campus and is one of several therapeutic areas including cardiovascular and metabolic disease,
respiratory, HIV/infectious diseases and emergency and critical care, which come together under the
overarching, UKCRC fully registered, Imperial Clinical Trials Unit (ICTU).
The ICTU-Ca team, having successfully developed and run multinational breast cancer trials through the
International Collaborative Cancer Group (ICCG) for over 25 years under the academic leadership of
Professor Charles Coombes, have more recently extended the remit of the unit to undertake research
activities in all phases of drug / device development (from Ib to IV) across multiple sites of disease including
breast, colorectal, ovarian, lung and prostate cancer and to include new and exciting imaging modalities and
translational research initiatives as they evolve.
The purpose of the post:
An experienced Clinical Trials Manager is required to oversee several national / international multi-centred
randomised clinical trials and to manage the associated study staff. He/she will oversee all aspects of trial
management, implementing systems to ensure that trials are developed and conducted to the highest
scientific and regulatory standards, and will also actively coordinate individual studies as required.
In addition, the post holder will assist the Senior Trials Manager and Academic leads to expand the Unit’s
portfolio by developing new trials and initiatives.
Key responsibilities and duties:
Trial Management
 Oversee trial coordination, data management and administrative activities to ensure the smooth running
and progress of trials.
 Work closely with CIs, senior statisticians, academic collaborators and funding partners to ensure good
communication between all parties.
 Ensure trials have ongoing compliance with appropriate ethical and regulatory requirements.
 Ensure the safe conduct of the trial with adherence to necessary pharmacovigilance e.g. reporting of
adverse events, expedited SAE/SAR/SUSAR reporting and submission of Development Safety Update
Reports.
 Review and continually refine trial systems and processes to ensure efficiency, effectiveness and
standardisation.
 Develop and implement comprehensive procedures for timely and clear reporting of trial status including
progress and recruitment rates
 Oversee the efficient supply of investigational drugs to trial centres.
 Ensure, together with other members of the group, that a 9am – 5pm randomisation service is provided
for studies.
 Oversee the implementation of study databases.
 Manage timely and efficient procedures for collection, computer entry and verification of patient data.
 Coordinate and support the activities of Trial Management Groups, Steering Committees, Data Monitoring
Committees and larger collaborative groups.
 Promotion of the portfolio by preparing newsletters and posters, and making presentations and at local,
national and international meetings.
 Contribute to the writing of scientific papers
 Have line management responsibility for the associated trial coordinators, monitors and data managers
including ensuring fair selection during recruitment, training records are kept up to date and conducting
regular Personal Review and Development Plans to ensure ongoing staff development.
Portfolio Development
 Contribute to the development of new studies under the guidance of the Senior Trials Manager and
clinical lead.
 Advise on trial management issues at the design phase.
 Contribute to writing protocols and other trial documentation i.e. Case Report Forms, Patient Information
Sheet and manage version control.
 Assist with the development and submission of funding applications.
 Contribute to regulatory applications and ethics submissions.
 Ensure the successful launch of new trials in conjunction with the CI and Trial Coordinator by arranging
and / or presenting at relevant meetings.
Finance
 Monitor trial grants, reviewing expenditure against budget and ensuring adherence to terms of all relevant
contracts.
 Oversee payments made to investigators and assist with development of payment / tracking systems to
ensure accountability.
 Liaise with Divisional/Departmental Administration and the Joint Research Office to oversee contractual
arrangements (including the development of new contracts) with outside organisations.
General
 Be responsible for all ICTU-Ca Tissue Access Committees for all closed studies.
 Support the Senior Clinical Trial Manager in the operational day-to-day management of ICTU-Ca,
deputising when required.
 Liaise with other Trials Managers to manage workloads of the data managers performing the data entry
and data management for trials.
 Represent the group at national and international meetings.
 Assist with the preparation and conduct for any future GCP Inspection.
 Be familiar with the relevant clinical literature and keep up-to-date with literature relating to clinical
research / trial methodology.
 Perform any other duties which may be required that are consistent with the nature and grade of the post
as required by the Chief Investigator.
Other Responsibilities:
 Observe and comply with all College policies and regulations, including the key policies and procedures
on Confidentiality, Conflict of Interest, Data Protection, Equal Opportunities, Financial Regulations, Health
and Safety, Imperial Expectations (for new leaders, managers and supervisors), Information Technology,
Private Engagements and Register of Interests, and Smoking
 Undertake specific safety responsibilities relevant to individual roles, as set out on the College Website
Health
and
Safety
Structure
and
Responsibilities
page
(http://www3.imperial.ac.uk/safety/policies/organisationandarrangements)
Job descriptions cannot be exhaustive and the post-holder may be required to undertake other
duties, which are broadly in line with the above key responsibilities.
Imperial College is committed to equality of opportunity and to eliminating discrimination. All
employees are expected to adhere to the principles set out in its Equal Opportunities in Employment
Policy, Promoting Race Equality Policy and all other relevant guidance/practice frameworks.
PERSON SPECIFICATION
Qualifications
Essential
 Degree or equivalent in biomedical/scientific/statistical or allied field.
Desirable
 Postgraduate qualification or equivalent, which includes clinical trials methodology.
Experience and Knowledge
Essential
 Proven clinical trial/project management experience gained in a number of multi-centre, phase II/III,
randomised IMP trials preferably in an NHS / academic environment.
 Working knowledge of the EU Clinical Trials Directive, UK Clinical Trials regulations, Principles of
GCP, Data Protection Act and Research Governance Framework legislation and proven ability to
apply these to the coordination of clinical trials.
 Evidence of preparing regulatory and ethics submissions, writing/amending protocols, PIS, CRFs
and other relevant trial management documentation.
 Experience of managing and developing staff.
 Demonstrated success in the management of clinical trials budgets.
 Evidence of strong IT literacy (MS Office).
 Evidence of managing translational research.
Desirable
 Experience of working on International trials (including Europe, Asia and USA).
 Evidence of working in Cancer field.
 Experience of preparing publications.
 Experience developing and submitting grant applications.
 Evidence of using database applications.
 Knowledge of EU languages.
Abilities and Skills
Essential
 Strong leadership and motivational skills.
 Evidence of ability to work independently as well as part of a team.
 Evidence of effective communication, negotiation, presentation and inter-personal skills.
 Evidence of ability to work with critical attention to detail and high levels of accuracy.
 Proven excellent organisational and time management skills to effectively handle conflicting priorities
and ensure tight deadlines are met.
Other
Essential
 Willingness to travel within the UK and internationally.
 Flexibility to working hours.
Imperial Expectations
These are the 7 principles that Imperial leaders, managers and supervisors are expected to follow:
1)
2)
3)
4)
5)
6)
7)
Champion a positive approach to change and opportunity
Communicate regularly and effectively within, and across, teams
Consider the thoughts and expectations of others
Deliver positive outcomes
Encourage inclusive participation and eliminate discrimination
Support and develop staff to optimise talent
Work in a planned and managed way
APPLICATION GUIDANCE
Please read the person specification carefully and describe, as part of your application, how much you feel
you meet each of the criteria.
Thank you for your interest in this post. We look forward to receiving your application.