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Royal Free and University College Medical School UCL MEDICAL SCHOOL UCL INSITUTE OF EPIDEMIOLOGY & HEALTH CARE Research Department of Primary Care & Population Health SENIOR DATA MANAGER (UCL PRIMENT CLINICAL TRIALS UNIT) This post provides a unique and exciting opportunity to develop and deliver the data management service provided by the Priment Clinical Trials Unit (CTU) to collaborating academics and clinicians, both within UCL and externally. The post-holder will oversee data management activities required to support the CTU portfolio of research studies, which consists of both CTIMP and non-CTIMP studies, in collaboration with the CTU Database Developer. They will have specific duties developing standardised database management tools, assisting with database development, overseeing provision of data management support and more general responsibilities including problem solving, assisting with data management and providing support using data management tools. 1. BACKGROUND INFORMATION 1.1 PRIMENT CTU Priment CTU is collaboration between the UCL Research Department of Primary Care and Population Health and the UCL Division of Psychiatry. The CTU coordinates and runs randomised control trials (RCTs) and other large cohort studies. The Directors of the CTU at UCL are Professor Irwin Nazareth and Professor Michael King. The UCL academic collaboration behind this 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. The strategic direction of Priment CTU has evolved from the research activities undertaken by the collaboration and includes the evaluation of cognitive behaviour therapy and other interventions for depression in primary care, smoking cessation interventions, care packages for severe mental illnesses in primary care, the evaluation of common treatments in primary care, and the implementation of treatments in general practice and community mental health. The UCL collaboration has several specific themes within it, such as mental health (to include severe and common mental disorders) e-health, dementias and trials and statistics methods. Each team is multidisciplinary and supported by administrative staff, and the CTU as a whole has both statistical and health economics expertise. www.ucl.ac.uk/priment/ 1.2 RESEARCH DEPARTMENT OF PRIMARY CARE & POPULATION HEALTH The Research Department of Primary Care and Population Health is part of the Institute of Epidemiology and Health Care and is headed by Professor Irwin Nazareth. 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. 1.3 DIVISION OF PSYCHIATRY The Division of Psychiatry at UCL specialises in clinical research, psychiatric epidemiology, molecular genetics, health services research and randomised trials of complex treatments in primary and secondary health care. The Unit is part of the Faculty of Brain Sciences and is headed by Professor Michael King. 1 2. DETAILS OF THE POST Accountable To: Prof Nick Freemantle, Priment Joint Statistical Lead Based At: Royal Free Hospital, Hampstead and Maple House, Tottenham Court Road 2.1 DUTIES AND RESPONSIBILITIES The post holder will be supported in their role by the Trial Operations Manager and the IT/Database Developer. In addition he/she will work closely with trial teams, including trial managers and data managers. Main duties will include: Advising trial team members with case report form design Designing electronic case report forms specifications Specifying checks for data validation using the protocol and study specific documentation Working with an external database supplier to deliver study databases Ensuring trial data management procedures meet current regulatory requirements Assisting trial managers and data managers in carrying out database queries and producing reports Providing database and data management training and assistance to trial team members Liaising with the trial team regarding database requirements Advising on testing trial databases Working with the CTU Database Developer to: keep an oversight of data management requirements within the CTU trial portfolio develop a team of data management support staff to provide trial-specific support ensure the timely design and provision of clinical and administrative databases enable database consistency throughout the CTU develop new standardised procedures, and review and amend existing procedures as appropriate develop and deliver new Data Management systems, procedures and related training The post holder may also be required to undertake trial specific responsibilities which may involve the following activities: Carrying out testing on trial databases Checking data for errors and ensure full documentation of any data queries are raised Randomising /registering patients, ensuring protocol entry criteria are met Data entry As a member of a team the post holder will provide cover for other trials within the team and in the department. In addition he/she will be expected to play a full part in departmental duties and undertake any other duties commensurate with the grade and purpose of the post. 2 3. PERSON SPECIFICATION Importanc Assessed by: e: A=application E=essential I=interview D=desirabl e Qualifications A degree, or equivalent, in a subject allied to information technology, E A computer science, or mathematics or relevant experience Experience/Knowledge Significant experience of data management E A / I Experience of clinical trials including an understanding of current E A / I regulatory requirements regarding data management in clinical trials Experience of contributing to and/or writing Standard Operating E A / I Procedures Experience of using a Clinical Data Management System, for example, E A / I MACRO, OpenClinica or RAVE Experience of designing electronic case report forms and checks for data E A / I validations Experience of report writing D A / I Familiarity with data collection within a primary care environment D A / I Skills Proven accuracy and numeracy skills E A / I Excellent communication skills (written and oral) E A / I Ability to organise and prioritise work effectively E A / I Ability to work to deadlines E A / I Ability to use Microsoft Word and Excel at an advanced level E A / I Ability to work unsupervised, taking responsibility for own actions E A / I Ability to work as part of a multi-disciplinary team E A / I 4. CONDITIONS OF APPOINTMENT Appointment The salary for this post is Grade 7 (points 29 to 36) currently £33,353 to £40,313 including £2,919 London Allowance per annum. Progression through the salary scale is incremental following satisfactory completion of probationary period. Cost of living pay awards are negotiated nationally and are normally effective from 1st August each year. Funding for this post is available for 24 months in the first instance and is supported by NIHR. Terms and Conditions and Staff Benefits Please follow the links in the advertisement for information on UCL Terms and Conditions for Research and Support Staff and Employee Benefits. Diversity in the Workplace UCL recognises that in our society, individuals and groups are discriminated against both directly and indirectly on the grounds of: age, colour, disability, ethnic origin, gender, HIV status, marital, social or economic status, nationality, race, religious beliefs, responsibility for dependants, sexual orientation, trades union membership or unrelated criminal convictions. 3 To counteract discrimination, UCL is committed to actively opposing all forms of discrimination, raising awareness and tackling the causes and consequences. It is committed to providing a learning and working environment in which the rights and dignity of all its members are respected and which is free from discrimination, prejudice, intimidation and all forms of harassment including bullying; to making staff and students feel valued, motivated and enabled to do their best work and to creating a safe, welcoming working environment accessible to all. The need to continuously update and improve our knowledge and skills in regard to assuring diversity means that all our courses include and address relevant aspects of the diversity agenda as required. The online training consists of a package called Diversity in the Workplace and provides essential, up to date information about Diversity in UCL. It takes about an hour to complete. Completion is a requirement for all new starters within 6 weeks of joining UCL; details will be provided with their contract of employment. Royal Free Campus Sharing a modern building with the Royal Free Hospital, the campus is situated in an attractive area close to the shopping centre of Hampstead and conveniently placed for public transport (bus, London Underground Northern Line and London Overground from Stratford to Richmond.) Hampstead Heath is a few minutes’ walk from the hospital. Facilities on site include dining facilities, a coffee lounge and snack bar, Recreation Centre (with
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