LONDON’S GLOBAL UNIVERSITY

UCL INSTITUTE OF EPIDEMIOLOGY & HEALTH CARE

Job Description
Clinical Project Manager for Data Grade: 8 (£52,487 - £61,534 inclusive of
Management London Allowance per annum)

Research Department of Primary Care and Location: Royal Free Campus / hybrid
Population Health working

Reports to
Anne Marie Downey, Head of Clinical Trial Operations

Context
PRIMENT Clinical Trials Unit (CTU) mission is to advance the quality, range and design of clinical trials in
primary care, mental health and community settings in order to improve the health of the population. PRIMENT
CTU is a partnership between 3 UCL departments:

• Research Department of Primary Care & Population Health

• Division of Psychiatry
• Department of Statistical Science

PRIMENT CTU conducts high quality randomised trials and related studies in mental health and primary care.
The unit has a particular focus on mental health and behavioural change interventions. PRIMENT CTU
collaborates with internal and external researchers to develop and/or evaluate complex interventions in primary
care, psychiatric and community settings. PRIMENT CTU is a UK Clinical Research Collaboration (UKCRC)
registered clinical trials unit. UKCRC registration recognises the CTU's strengths in conducting major trials and
other large, well-designed studies.

The Directors of the CTU at UCL are Professor Irwin Nazareth and Professor Greta Rait. The PRIMENT CTU
Steering Group is supported by the Operational Group, a scientific and clinical team including trialists,
statisticians, health economists, qualitative research experts and trial managers.

The Priment academic collaboration has existed for over 15 years and consists of multidisciplinary teams
including clinical researchers in psychiatry, primary care, psychology, palliative care, nursing, epidemiology,
trial management and statistics. Over the years this group has conducted clinical trials and other large studies
on severe mental illnesses, common mental disorders (i.e. depression and anxiety disorders) and other common
clinical conditions in primary care.

Main purpose of the job

The primary role of the post holder is to establish, implement and deliver a high quality data management service
to collaborating academics and clinicians both within UCL and externally. The post holder will be responsible
for ensuring this service is performed to the highest standard and meets GCP and other regulatory requirements.
The post holder will work as a member of the CTU Operational team and will lead on the delivery and
implementation of Priment Clinical Trials Unit (CTU) Data management strategy required to support the CTU
portfolio of research studies, which consists of both CTIMP and non-CTIMP studies. The post holder will also
have duties in delivering trial specific clinical data management systems.

HR USE ONLY: Position no: B02-08228 HERA no: 004818

Duties and responsibilities
• Development and implementation of PRIMENT CTU Standard Operating Procedures (SOPs) and Policies
for data mangement and oversee it’s compliance.
• Assist with the Operations team with vendor assessments/audits for data handling systems and other
software.
• Provide strategic input into improving PRIMENT CTU data management and data handling methods and
oversee it’s implementation to ensure improvement to quality, reliability, timelines and cost effectiveness
of clinical trials is achieved at PRIMENT CTU.
• Costings for databases and provide data management input to grant applications and input throughout the
life cycle of a trial.
• Lead on the delivery of data management systems for trials that have successly obtained funding
including:
o Design and development of trial specific databases.
o Develop and approve trial-specific data management documents.
o Identify and strategically implement solutions to problems relating to data management throughout the
trial lifecycle.
o Ensure timelines for database release and other trial deliverables are provided in a timely manner.
• Ensure robust measures are in place for data security and confidentiality throughout the trial lifecycle,
including:
o Review and approve trial specific data protection registrations and Data Protection Impact
Assessments.
o Managing user access to trial databases.
o Strategic input to trial specific risk mitigations and risk based central monitoring of trial data.
o Strategic input to any potential serious breaches and oversee implementation of corrective and
preventative actions.
o Ensure trial data is adequate and available for sharing with internal and external stakeholders and
oversee the data sharing processes and agreements.
• Lead on delivery and develop data management training programme to internal and external
stakeholders.
• Lead on the cross department, institute and faculty data management and software working groups to
ensure the successful database and trial software systems are in operation at PRIMENT CTU.
• Chair PRIMENT CTU Data Management Group and actively participate at PRIMENT CTU strategic Data
Management and IT Data Management Oversight Group meetings.
• Line management of Senior and Junior Data Managers including the allocation of data management team
members across PRIMENT CTU trials portfolio
• Oversight of the maintainenance of PRIMENT CTU electronic quality management system and other
electronic systems used by the CTU.
• The post holder will contribute to the work undertaken by the CTU Operational team. This will include:
• Participating in preparations for, and assisting CTU staff in preparing for external audits and inspections by
regulatory authorities.
• Being knowledgeable and up-to-date with new developments in trial regulations and clinical research.

General

• General administrative duties including setting up meetings, preparing agendas and minute taking.
• Co-ordinate own work with others to avoid conflict or duplication.
• The post-holder will actively follow UCL policies including Equal Opportunities and Race Equality policies.
• To act as a Fire Evacuation Marshall as required and maintain an awareness and observation of Fire and
Health & Safety Regulations
• Carrying out duties in a resource-efficient way and actively support UCL’s Sustainability Strategy.
• Follow and actively promote the UCL Ways of Working.
• Carry out any other duties within the scope, spirit and purpose of the job as requested by the line manager.
• This job description may be reviewed and be subject to amendment in consultation with the post holder.
• UCL offers hybrid working where appropriate and the successful applicant may normally work remotely for
up to 40% of the week subject to agreement with their line manager.
Person Specification
Note to job applicant: copy and paste the following criteria into your “Statement in support of your application” and
describe underneath each criteria how you meet it, giving examples. You will be scored on how you meet each criteria.

Essential Criteria Assessment method

Qualifications, experience and knowledge

A degree, or equivalent, in a subject allied to information technology, computer science, or Application Form
mathematics or significant relevant clinical trial data management experience
Significant experience of data management in clinical trials including an in depth Application Form/Interview
knowledge of clinical trials methodology, UK Clinical Trials Regulation, ICH Good Clinical
Practice, the European Clinical Trial Directive Clinical Trials, the UK policy framework for
health and social care research and General Data Protection Regulation and the Data
Protection Act.
Experience of contributing to and/or writing Standard Operating Procedures. Application Form
Experience of using a Clinical Data Management System (for example, REDCAP, Application Form/Interview
MACRO, OpenClinica or RAVE), including its development and user acceptance testing.
Skills and abilities

Excellent interpersonal and communication skills (written and oral) and proven accuracy Application Form
and numeracy skills.
Abilities to evaluate risks inherent to research projects. Interview
Ability to use Microsoft Word and Excel at an advanced level and have good knowledge of Application Form
SQL and other database concepts.
Willingness to travel to other trial sites within the uK Application Form
UCL Ways of Working

Have a flexible approach to work, ability to use own initiative, is self-motivated, organised, Interview
meet deadlines, able to work unsupervised and taking responsibility for own actions.
Excellent attention to detail and takes pride in delivering an excellent research service to Interview
colleagues, students, partners and the wider community.
Willingness and ability to acquire new knowledge/ skills and sharing relevant knowledge to Application Form
colleagues, staff, students and partners.
Leadership skills and able to work as part of a multi-disciplinary team and respond Application Form/Interview
proactively and appropriately to the needs of colleagues, staff, students and partners.
Desirable Criteria

Commitment to and knowledge of advancing equality, diversity and inclusion Application Form/Interview

Experience of line Management of staff and overseeing staff workloads to ensure Application Form/Interview
timelines and deadlines are met.
Familiarity with data collection within a primary care environment. Application Form
Background Information
Research Department of Primary Care and Population Health (PCPH)
The Research Department of Primary Care and Population Health is part of the Institute of Epidemiology and Health Care
and is co-led by Professor Greta Rait and Professor Kate Walters. The Department’s strategic aim is to deliver high-quality
teaching in community-based primary care and public health and to undertake a programme of internationally competitive
multi-disciplinary research addressing the management and prevention of disease in individuals and populations in areas
which are of priority to the health of the public. Further information can be found at: http://www.ucl.ac.uk/pcph/

Institute of Epidemiology & Health Care (IEHC)

The Institute of Epidemiology and Health Care is part of the Faculty of Population Health Sciences within the UCL School
of Life and Medical Sciences (incorporating UCL Medical School). Further information on IEHC can be found at:
http://www.ucl.ac.uk/iehc/

How to Apply
Apply through the UCL website.

If you have any informal queries about the post, please contact Anne Marie Downey (Email: [email protected])

If you have any enquiries about the application process or if you have any difficulties accessing the online recruitment
system, please contact the PCPH HR Administrator (Email: [email protected])