Imperial College London
Job Description
Job Title:
Senior Clinical Trials Manager
Department:
Medicine
Division:
Infectious Diseases
Section:
Paediatrics
Group:
Neonatal Medicine
Job Family/Level:
Professional Services, Level 4
Salary Range:
£42,670 - £50,190 per annum
Responsible To:
Dr Sudhin Thayyil (Reader in Neonatal Medicine, Imperial College
London)
Location:
Hammersmith Campus and St Mary’s Campus; Imperial College
Healthcare Trust (SMH and QCCH).
Liaises with:
Internal:
Director of Research, Joint Research Compliance Office, Joint
Research Office, Divisional/Clinical Programme Group Administrators,
Chief and Principal Investigators, Insurance Office, Research
Contracting Unit, Statistical Advisory Service, NHS and College
Departments and support staff, Department of Paediatrics, and
Medicine.
External:
NHS R&D Managers, Ethics Committees, Officers of Medical
Charities, Research Councils and other grant giving bodies; R&D
managers of major pharmaceutical and other industrial companies
involved in clinical trials; HRA; MHRA; HTA; CLRN;NIHR.
Duration:
Full-time, fixed-term until 31 September 2015, with possible extension
(subject to further funding). The job is available to start immediately.
Background
Imperial College London is a referral centre for neonatal neurology and was the first hospital
in the world to have a dedicated 3 Telsa MR scanner located inside the neonatal unit for brain
research. Imperial College have a long standing tradition of world leading research into
neonatal neurology, including pioneering work into rescue hypothermic neuro protection.
The neonatal brain research group includes MR physicists, radiographer, clinical fellows,
research nurses, neonatal neurologist, and is led by Dr Sudhin Thayyil. The ongoing work of
the group includes first-in-human studies into Xenon (Cool Xenon) and N-acetyl cysteine as
an adjunct to cooling in neonatal encephalopathy (NAChilD), and clinical studies of neuro
protection in low- and middle-income countries (HELIX trial).
Summary of the Post
The primary purpose of the Senior Clinical Trials Manager is to lead in the efficient
management of a portfolio of studies including NAChilD, Cool Xenon 3 and HELIX, ensuring
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projects are run to target and in line with regulations in place. The post holder will need to
have expertise in research management, including clinical trials of investigational medicinal
products (CTIMPs), ICH-GCP, clinical and research governance, patient recruitment,
preparing standard operating procedures for trials, data management and curation. They will
also need to have a familiarity of the National Health Service (NHS) and National Institute of
Health Research (NIHR) processes and procedures, and liaison with NHS Hospital Trusts.
They will lead and co-ordinate the logistical aspects of clinical trials in compliance with Good
Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs). They will also
act as a pivotal point of contact and support for the clinical trial team/research team.
Primary Roles & Responsibilities
The objectives of the job are to manage the research activities of the Department, namely
project management of the growing study portfolio, ensure the studies are recruited to target
and within budget and in accordance with ICH-GCP, local clinical and research governance
guidelines. This will include:
Project Management

Setting up and maintaining effective quality systems for the studies.
This includes set up, initiation, monitoring, close down and archiving of studies and the
management of overall conduct for these studies, including CTIMPs.

To write reports and study specific standard operating procedures in accordance to local
guidelines, study protocols and regulatory requirements on the set up, initiation,
monitoring and close-down of clinical trials, including planning and implementing
corrective and preventive actions and to follow up until resolution.
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To provide training and mentoring to staff conducting CTIMPs on clinical trials regulations
and GCP conduct.
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To manage and update the quality systems for CTIMPs ensuring implementation of EU
Clinical trials directive and UK regulations and take overall responsibility for maintenance
and implementation of Standard Operating Procedures (SOPs), policies, guidelines and
forms including version control, quality control review, revisions and archiving.

To ensure Investigators and staff are notified about SOPs, policies and guidelines relevant
to their role and log their receipt and understanding and provide necessary training for
implementation.
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To lead the Department’s pharmacovigilance activities for CTIMPs which includes
ensuring appropriate reporting of Adverse Events, Suspected Unexpected Serious
Adverse Reactions, GCP and protocol breaches, deviations, violations and premature
withdrawal of protocol to the MHRA and Ethics, and implementing corrective and
preventive actions.
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To ensure annual safety and progress reports and are prepared and sent adhering to
national guidelines and regulatory requirements.
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To support Chief Investigators with applications for new clinical trials; be the first point of
contact, offer advice on regulatory and ethical requirements, and identify appropriate
steps until resolution.
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To support Chief and/or Principal Investigators in the preparation and development of
documents required to be submitted to regulatory and ethical authorities and other
relevant committees for approval of CTIMPs.
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To ensure the quality control and review of key study documents including protocols,
Participant Information Sheets and regulatory and ethics committee submissions.

To provide support in the finalising of all trial agreements required to be in place prior to
trial commencement.
Trial Coordination

To maintain Trial Master files as required by Sponsor, ensuring they are ready for
impromptu audits and MHRA inspections for the CTIMPs.

To prepare and submit amendments to the study documentations, seeking regulatory
approvals for amendments and local R&D approvals prior to implementing at sites.

To ensure accurate and timely data entry onto the appropriate databases, as set-out in
the protocols.

To provide regular reports to funders, as requested.

To organise and minute meetings relating to ongoing studies.

To manage trial documentation according to scientific requirements of the protocol and in
line with the regulations.

To promote the trial to ensure wide participation and good accrual of patients including the
production of newsletters, co-ordination of site visits and meetings, and presenting
information about the trials.

To work closely with the JRO/JRCO teams in tracking contract and governance
progression in study work up.

To liaise with study coordinating centres to ensure professional communication on study
progression at Imperial College London.

To work closely with the Divisional Research Manager to ensure study contract funding is
invoiced and internal income share allocated as agreed.

To co-ordinate the collating, tracking and shipping of CRFs and data queries to Data
Management.

To co-ordinate archiving of study documentation according to the JRCO SOP.

To co-ordinate the purchasing, delivery and coordination of the trial supplies.

To ensure site accountability processes are in place and being followed if required.

To prepare and present written and oral reports to the Division, Department, European
Commission, National Ethics Committee (UK) or other groups and/or at scientific
meetings.
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To draft, implementing and maintaining efficient and responsive administrative and data
management processes to ensure the smooth and effective conduct of the study.

To contributing to grant applications, ethics/regulatory submissions and monitoring
submissions and approvals for the study.

To contribute to journals submissions as required by the Chief Investigator.

To be responsible for ensuring that data is accurate, up to date and complete.
Monitoring

To be responsible for the monitoring, conduct, progress review and documentation of all
the studies on portfolio by reviewing sponsor and site trial documents and performing
source document verification (SDV).

Initiate and oversee monitoring plans for CTIMPs, working with the Sponsor.

Ensure that the monitoring plans for multi-site clinical trials are reviewed and approved by
the Sponsor prior to trial initiation.

To ensure that all appropriate medication manufacture, supply and release documentation
is in place before the trial commences.

To ensure all study specific SOPs are adhered to and in particular the recording, reporting
and tracking of Serious Adverse Events and Adverse Reactions.

To coordinate trial initiation visits at each site before any research activity commences, to
include review of facilities where trial activity is taking place and obtaining a signed
Investigator agreement highlighting research responsibilities.

To ensure each CTIMP has a system for documenting IMP drug accountability and
traceability which can be sent to Sponsor, as required.
Service Delivery:

Establish and maintain the study master files and investigator site files in accordance with
ICH-GCP and Research Governance.

Prepare and submit appropriate revisions of ethics and R&D approval forms.

Identify data management issues that require onward reporting to the Principal
Investigators and produce a data management plan for the study in collaboration with the
study team.

Produce reports on timelines to data entry, recruitment, missing data, visit timelines,
database warnings, discrepancy levels, outliers.

Monitor data flow through the study.

Manage the clinical data extract process for the study and database entry.

Advise the Principal Investigators promptly if any concerns about data quality are
identified.
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Manage relevant study documentation, including communications to parents and their
doctors.
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Organise meetings and training days during the setting up phase of study sites.
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Draft relevant study reports including reporting of safety data.

General clerical and office management duties including maintaining efficient study filing
systems.

Ensure sites have relevant study materials (e.g. site files, sample packs).

Ensure clear documentation with regards to conventions, data changes, errors and
correspondence with collaborators.
Analysis & Research:

Work with the database manager to produce a final data set for the analysis and manage
the database.

Use initiative and be proactive about learning new skills relevant to the prosecution of
clinical trials.
Communication & Networking:

Work seamlessly with the Principal Investigator and the CPG5 Research Manager to
facilitate the smooth running of the trial.

Communicate complex information both orally and in writing.

Participate in project meetings as required.

Ensure clear communication at all times to a multidisciplinary study team consisting of
clinical research and laboratory staff and physicians.

Liaise with collaborating research NHS and NIHR staff to ensure efficient and effective
processes and procedures.

Recognise when/if a change in procedure/legislation has implications for the study and
Department. Identify who will need to know about it, ensuring that the information is
disseminated appropriately.
Organisational Chart
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Other Duties:

To observe and comply with all College policies and regulations, including the key policies
and procedures on Confidentiality, Conflict of Interest, Data Protection, Equal
Opportunities, Ethics related, External Interests, Financial Regulations, Health and Safety,
Imperial Expectations (for new leaders, managers and supervisors), Information
Technology, and Smoking.

To undertake specific safety responsibilities relevant to individual roles, as set out on the
College Website Health and Safety Structure and Responsibilities web 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 London is committed to equality and valuing diversity.
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Person Specification
Candidates/postholders will be expected to demonstrate the following:
Qualifications
Essential
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Degree in Biological Science or Health-related subject (or equivalent experience)
PhD in a related subject
Knowledge and skills
Essential
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Knowledge of NHS and NIHR research processes
Knowledge of ICH GCP
Knowledge of Industry/Clinical trial processes
Knowledge of the Data Protection Act and Information Governance
Knowledge of national and international regulatory approval processes
Accredited to provide GCP training
Well-developed interpersonal and negotiating skills
Strong administrative, organisational and time management skills
Excellent written and oral communication skills
Excellent numeracy skills and attention to detail including financial capability for
monitoring invoices and payments
Excellent computer literacy – ability to use Microsoft Office applications at an
advanced level and in developing and maintaining Databases (for example
Redcap)
Experience
Essential
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Experience of clinical and research governance processes
Experience of updating and submitting applications for ethical and regulatory
approval
Experience of using a clinical trials database or data system
Experience of working in clinical translational research and conducting research
projects
Experience of co-ordinating and contributing to the development of policies and
Standard Operating Procedures
Experience of preparing reports for internal and external review
Experience of setting up clinical studies
Experience in using IRAS
Experience in project coordination/management
Experience of working with confidential information and of working with vulnerable
patients
Experience of working in a multi-disciplinary team in a clinical and research
academic environment
Experience of working within a large and complex organisation
Experience of clinical trial management and co-ordination, and a full
understanding of research related issues on an organisational level
Experience of writing and/or co-ordinating ethics and MHRA submissions
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Knowledge and expertise in research governance concepts and GMP/GCP/QP
Thorough knowledge of clinical trials regulations
Demonstrable knowledge of clinical trial processes, funding and clinical trials in
Higher Education, the NHS or a commercial trials unit
Experience of working with a clinical trials database
Others
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Willing and able to travel nationally and internationally
Imperial Expectations
These are the 7 principles that Imperial leaders, managers and supervisors are expected to
follow:
1) Champion a positive approach to change and opportunity
2) Communicate regularly and effectively within, and across, teams
3) Consider the thoughts and expectations of others
4) Deliver positive outcomes
5) Encourage inclusive participation and eliminate discrimination
6) Support and develop staff to optimise talent
7) Work in a planned and managed way
As this post is exempt from the Rehabilitation of Offenders Act 1974, a satisfactory
(standard/enhanced/enhanced for regulated activity) Disclosure and Barring Service check
will be required for the successful candidate.
Further information about the DBS disclosure process can be found at
http://www.homeoffice.gov.uk/agencies-public-bodies/dbs/ or by telephoning 0870 90 90 811.
You may also wish to view the College’s policy statements on the Recruitment and
Employment of Ex-Offenders and the Secure Storage, Use, Retention & Disposal of
Disclosures and Disclosure Information.
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