JOB DESCRIPTION
Post Title: IT Programmer, Clinical Trials Unit
Department/Division/
Department of Biostatistics
Directorate:
Grade: 6
Responsible to: Ms Caroline Murphy, CTU Manager
ROLE PURPOSE
• Maintenance of the CTU’s website (www.ctu.co.uk), IT infrastructure, InferMed MACRO
database system, randomisation service, Access databases and supporting
documentation
• Provide advice and technical support to the unit’s data managers on complex
programming issues within the InferMed MACRO system
• Support the CTU statisticians with appropriate IT solutions
ROLE OUTLINE – MAIN RESPONSIBILITIES
Key Objectives:
• Evaluate user needs and system functionality ensuring that the appropriate facilities in IT
meet these needs
• Develop, unit test, document, perform change control of and maintain databases for
clinical trials (including modifications during trial conduct) for both InferMed MACRO
system and randomisation system
• Program administrative data reports as needed for trials using InferMed MACRO
• Develop and modify eCRFs as needed, in collaboration with the Unit data managers
• Perform electronic data loads
• Ensure adequate version control of all files
• Provide relevant documentation and data for archiving
• Upgrade the database, data entry screens, external data load programs and check
programs to new versions
• Assign/restrict access rights to clinical trial databases
• Lock/unlock databases as requested
• System maintenance and process improvements, including security back-ups
• Contribute to the continuous improvement, re-engineering and implementation of
processes, tools, technologies, conventions, standards, policies, Standard Operating
Procedures (SOPs), and guidelines as needed
• Monitor and stay abreast of technological, legal and operational changes
• Train and give guidance to staff on the use of the applications (either existing or new
ones)
• Keep up to date with knowledge on job related topics
• Be up to date with SOPs and user manuals and maintain training log
• Observe and comply with all KCL policies and regulations
Communication & Networking:
• Communicate with KCL ISS (Information Services and Systems) department and IoP
Computing Department to ensure appropriate hosting, access, maintenance and backup
of CTU database systems
• Communicate with study teams, data managers, trial managers and statisticians to find
appropriate and cost effective solutions to data management and randomisation needs
within trials
• Develop and maintain good links with UKCRC IT group, InferMed and other clinical trials
units
Decision Making, Planning and Problem Solving:
• Advise on clinical trials IT infrastructure at a College wide level
• Take responsibility for longer term IT projects within the CTU to maximise efficiency and
minimise costs of services to study teams
• Liaise with InferMed in relation to any technical issues with the system
• Research appropriate additional database systems to be used within the CTU
Service Delivery:
• Work to ensure a continuous online service to clients is available or communicate in
advance any planned disruptions in service due to maintenance work
• Liaise with KCL ISS and others to assess the seriousness of any unexpected
interruptions to service
• Work with the CTU manager, data managers and statisticians to ensure projects are
delivered on time and within budget
Analysis & Research:
• Keep up to date professionally with developments in the field
• Assess emerging technologies on an ongoing basis
• Advise CTU manager of most appropriate systems for use within the CTU
• Work to find optimal IT solutions within the CTU
Team Work, Teaching & Learning Support:
• Work closely with the CTU data managers and statisticians to ensure projects are
delivered
• Provide training as required
• Identify and discuss own training needs with CTU manager as appropriate
Sensory/Physical Demands & Work Environment:
• Computer based post
• Occasional lifting of computer equipment may be necessary when setting up machines
Organisational Chart:
MH&N CTU
ADVISORY BOARD
HEAD OF
BIOSTATISTICS
READER IN DEPARTMENTAL DEPARTMENTAL
BIOSTATISTICS BUSINESS MANAGER ADMINISTRATOR
CTU MANAGER LECTURER IN LECTURER IN LECTURER IN
MEDICAL STATISTICS BIOSTATISTICS BIOSTATISTICS
(CTU) (NUCLEUS)
ADMINISTATOR IT PROGRAMMER SENIOR DATA CORE AND 2 STATISTICIANS 2 STATISTICIANS
MANAGER PROJECT-SPECIFIC
TRIAL MANAGERS
CORE AND
PROJECT-SPECIFIC
DATA MANAGERS
Special Requirements:
• You will be required to work irregular hours occasionally, in accordance with the needs of
the role and specifically at times when upgrades to the system need to be run outside
normal working hours.
• Information of a confidential nature must be kept strictly confidential and should never be
disclosed either inside or outside work. It should be noted that breach of confidentiality is a
serious offence which may lead to dismissal.
• This appointment is subject to Occupational Health clearance. Should you be offered this post
you will be sent an Occupational Health Questionnaire along with your contract of
employment. When the Occupational Health Department have evaluated your questionnaire
and declared that you are fit for appointment, your appointment will be formally confirmed.
General:
All staff are expected to adhere to King’s policies and procedures.
Date: September 2010
Please note:
This job description reflects the core activities of the role and as the College and the post-holder
develop there will inevitably be changes in the emphasis of duties. It is expected that the post-
holder recognise this and adopt a flexible approach to work and be willing to participate in training.
If changes to the job become significant, the job description should be reviewed formally by the
post-holder and line manger. The HR Department should then be consulted as to the implications
of the proposed changes.
PERSON SPECIFICATION
CRITERIA E D HOW
S E IDENTIFIED
S S AND ASSESSED
E I AP = application
N R AS = assessment
T A
I = interview
I B
A L P = presentation
L E R = references
Education/qualification and training
• Degree or equivalent in computer science and/or equivalent health X AP
related field
• Educated to MSc level in a relevant subject X AP
Knowledge/skills
• Excellent knowledge of English X AP, I
• Wide experience of Microsoft Access database design and VBA X AP. I, AS
programming
• Experience and knowledge of SQL server X AP, I, AS
• InferMed MACRO programming experience X AP.I
• Excellent knowledge of regulations and guidance documents with X AP, I
regard to clinical trials and the systems used in this context (eg
21CFR11, GCP)
• Web coding using ASP and ASP.net, vbscript and Javascript. X AP, I
Knowledge of HTML CSS DHTML XML
• Excellent written, verbal and organisation skills X AP, I
• Familiarity with statistical software such as STATA/SAS/SPSS X AP, I
• Knowledge of Microsoft Office applications ( Word, Excel etc) X AP, I
Experience
• At least 2 years work experience in an IT role X AP, I, R
• Extensive, proven experience in clinical data management X AP
• Experience of working in a clinical trials unit or in academic X AP
research environment
• Extensive experience of using Visual Basic, SQL and Microsoft X AP, I AS
Access
Personal characteristics/other requirements
• Ability to handle multiple projects X I
• Ability to manage timelines and work to strict deadlines X I, R
• Mentoring and training skills X I
• Excellent team player X I, R
• Commitment to maintain continuous specialist development and to X I
keep up to date with new technology and available software
SUMMARY OF TERMS AND CONDITIONS OF SERVICE
The conditions of service will be those that apply to non Academic staff employed by the Institute
and include the following:
Salary It is Institute policy to appoint on the base of Grade 6 (range £33,070 pa to
£34,943 pa inclusive of London Allowance).
Hours Normal full time hours are 35 hours per week.
Holidays 27 working days per annum in addition to public holidays (pro-rata for part-timers).
Pension This appointment is superannuable under the USS pension scheme, the
employee's contribution normally being 6.35 % of salary.
Ticket Loan An interest free Season Ticket Loan is available for staff.
Canteen The Institute operates a staff canteen and members of staff also have access to
dining facilities at the Maudsley Hospital.
Probation The standard probationary period for Institute appointments is 6 months.
Term Fixed-term until March 31st 2012
References All Institute appointments are subject to receipt of satisfactory references and,
where appropriate, confirmation of qualifications.
Medical All Institute appointments are subject to a satisfactory medical report.
Smoking King’s College London is committed to maintaining a healthy environment for staff,
students and visitors. Therefore, please note that smoking is not permitted in any
of the College buildings or in College vehicles. Smoking is also not permitted
immediately outside the entrances to College buildings or near to windows and air
intake units. Staff working at associated NHS trust sites or other premises should
adhere to whatever policy is in place at these locations. For a full copy of the
College policy please visit:
http://www.kcl.ac.uk/content/1/c4/63/43/SmokingPolicyv2.doc
NB This information is provided as guidance only, and does not form part of the employment
contract.
BACKGROUND INFORMATION
THE COLLEGE
King's College London is one of the top 25 universities in the world (Times Higher Education 2009)
and the fourth oldest in England. A research-led university based in the heart of London, King's
has more than 21,000 students from nearly 140 countries, and more than 5,700 employees. King's
is in the second phase of a £1 billion redevelopment programme which is transforming its estate.
King's has an outstanding reputation for providing world-class teaching and cutting-edge research.
In the 2008 Research Assessment Exercise for British universities, 23 departments were ranked in
the top quartile of British universities; over half of our academic staff work in departments that are
in the top 10 per cent in the UK in their field and can thus be classed as world leading. The College
is in the top seven UK universities for research earnings and has an overall annual income of
nearly £450 million.
There are nine Schools of Study:
• Arts & Humanities
• Biomedical & Health Sciences
• Dental Institute
• Institute of Psychiatry
• Law
• Medicine
• Nursing & Midwifery
• Physical Sciences & Engineering
• Social Science & Public Policy
King's has a particularly distinguished reputation in the humanities, law, the sciences (including a
wide range of health areas such as psychiatry, medicine and dentistry) and social sciences
including international affairs. It has played a major role in many of the advances that have shaped
modern life, such as the discovery of the structure of DNA and research that led to the
development of radio, television, mobile phones and radar. It is the largest centre for the education
of healthcare professionals in Europe; no university has more Medical Research Council Centres.
King's College London and Guy's and St Thomas', King's College Hospital and South London and
Maudsley NHS Foundation Trusts are part of King's Health Partners. King's Health Partners
Academic Health Sciences Centre (AHSC) is a pioneering global collaboration between one of the
world's leading research-led universities and three of London's most successful NHS Foundation
Trusts, including leading teaching hospitals and comprehensive mental health services. For more
information, visit: www.kingshealthpartners.org.
THE INSTITUTE OF PSYCHIATRY
The Institute of Psychiatry is a postgraduate medical school associated with the South London and
Maudsley NHS Foundation Trust, and is a School of King's College London of the University of
London. It has an outstanding international reputation in the field of research. In the most recent
Research Assessment Exercise (2008), “the IOP had the largest number of world leading or
internationally excellent research activity units” for Psychiatry, Clinical Psychology and
Neuroscience in the UK. The Institute has approximately 870 students and 1000 staff and has an
annual budget of approximately £70 million. The Institute offers a range of Diploma, MSc, MPhil,
and PhD courses in psychiatry, psychology and related basic and clinical neurosciences.
The complementary roles of the Institute are
• to pioneer research into new and improved ways of understanding and treating mental
illness and brain disease;
• to offer advanced University training for psychiatrists, psychologists, neurologists and other
scientific and paramedical workers.
The Institute comprises 9 Academic Departments - Psychology, Psychiatry, Neuroscience, Clinical
Neuroscience, Child and Adolescent Psychiatry, Behavioural & Develomental
Psychiatry, Psychosis; Addictions, Old Age Psychiatry & Dementia ; two Research Centres;
Social, Genetic and Developmental Psychiatry Research Centre, Health Services and Population
Research Centre; and a full range of academic support services.
BIOSTATISTICS
The Clinical Trials Unit joined Biostatistics in 2008 (see below). A new Chair of Biostatistics will be
taking up post in August.
Research
Academic statisticians at the Institute conduct their own methodological research, as well as
collaborative research with academics within the Institute, nationally and internationally. We have a
longstanding reputation in the areas of measurement, multivariate analysis and
developmental/lifecourse analysis. Methodological research has been carried out in the areas of
longitudinal/multilevel modelling, structural equation modelling, reliability, multivariate methods,
spatial pattern analysis and neuroimaging, and the design of epidemiological studies. Members of
the department have collaborated on major substantive research projects, for example mixture
model mapping of brain activation in fMRI, treatment of depression by CBT, autism development,
diagnosis and genetics, gulf war syndrome, spatial interaction between brain cells in AIDS
associated dementia, and clustering of suicides among the mentally ill. Much of this work is
research council funded.
Teaching
The Group has an active teaching programme which contributes to the IOP’s general teaching
programmes on Behavioural Research Methodology. The Biostatistics Group provides specialist
courses in key statistical methodologies for behavioural research, training in statistical software
and a contribution to meeting training requirements in introductory statistics. Past specialist
teaching modules have included multilevel modelling, structural equation modelling, multivariate
methods, analysis of clinical trials and others. Members of the department also contribute to a
number of postgraduate taught courses in other departments.
Consultancy
The Biostatistics Group provide statistical and statistical computing advice to students and staff in
all other departments. The statistical advisory service operates via a web-based electronic
appointment system.
The Mental Health and Neurosciences Clinical Trials Unit (MH&N CTU)
The Mental Health & Neuroscience CTU is the only Clinical Trials Unit across the King’s Health
Partners organisations to be awarded full UKCRN registration and forms part of a Network of
CTU’s across the UK and Europe. The CTU was formed in 2002 with funding from the IOP, South
London and Maudsley NHS Trust and King’s College Hospital NHS Trust. Current funding is from
the Department of Health and the IoP. Historically the MH&N CTU was set up and directed by
Professor Simon Wessely and was part of the Department of Psychological Medicine. Since 2008
the Unit operates as a Section from within Biostatistics.
The MH&N CTU is the first in the United Kingdom to specialise predominantly in mental health. In
the first eight years of operation it has provided advice and support to a large number of grant
applications. It is currently involved with important trials such as PACE, SADD, RIOTT, CRIMSON,
UPBEAT, IMPACT, LiCALS and HSEN. These and other trials cover many aspects of mental
health and neuroscience, and include trials supported by the MRC, Wellcome, NIHR HTA
programme, medical charities and the pharmaceutical industry.
The MH&N CTU is currently staffed by a Clinical Trials Unit Manager, three statisticians, a
Database Programmer, a Data Manager, a Trial Manager and an Administrator (all full time). There
is an additional NIHR Research Methods Training Fellow in Statistical Methodology for Mental
Health Trials.
Statisticians across the Institute
The Institute encompasses statistical expertise in several areas, such as Epidemiology, Health
Economics, Neuroimaging and Statistical Genetics, providing a broad range of knowledge, and the
necessary critical mass for both successful statistical research and support of research
programmes. The local Research Design Service based at KCL has access to statistician support
within the organisation and refers mental health studies to the CTU or the wider biostatistics group.
External Links
The Group has close links with the University of Manchester Biostatistics Group (Professor
Graham Dunn), and the MRC Biostatics Unit (Dr Ian White) and Psychometric Centre (Dr Tim
Croudace) both at the University of Cambridge. We co-operate in the development of research
interests and an advanced training programme in behavioural/mental health statistics. Currently
staff are members of a Methodology Research Group funded by the Mental Health Research
Network.
APPLICATIONS
Applications should be made on the enclosed form and applicants may enclose a brief covering
letter highlighting experience and skills relevant to the vacancy. If you wish us to view your CV you
may enclose it with the covering letter and completed applications form.
Completed application form should be emailed to [email protected] or sent to the address
below:
Human Resources Office, Box 007,
Institute of Psychiatry,
De Crespigny Park,
London, SE5 8AF.
The closing date for applications is 22 September 2010.
Please quote reference number 10/P66.
Candidates who would like to discuss the post further are invited to contact Caroline
Murphy at [email protected] or go to www.ctu.co.uk
We very much regret that due to limited resources and the large number of applications we
currently receive, we are only able to inform shortlisted candidates of the outcome of their
application. If you do not hear from us within four weeks of the closing date, please assume that
you have been unsuccessful on this occasion. We would like to assure you, however, that every
application we receive is considered in detail and a shortlist only drawn up after careful reference
to a detailed person specification.
If therefore, your application is not successful, we hope that you will not be discouraged and will
still apply for other suitable vacancies at IOP as and when they are advertised
Equality of opportunity is College policy
