JOB DESCRIPTION. Northern Ireland Clinical Trials Unit (NICTU) Royal Hospitals, BELFAST LOCATION: BAND: Band 5 JOB SUMMARY/MAIN PURPOSE:

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1 JOB DESCRIPTION POST: LOCATION: Data Manager Northern Ireland Clinical Trials Unit (NICTU) Royal Hospitals, BELFAST BAND: Band 5 REPORTS TO: RESPONSIBLE TO: JOB SUMMARY/MAIN PURPOSE: Data Project Manager Director of NICTU As a Data Manager you will provide professional management and co-ordination of clinical research data, working with clinical staff to establish workloads, timelines and priorities. Your role will involve data collection, review and discrepancy management to ensure data quality and consistency. You will develop Case Report Forms (CRFs), Data Management Plans (DMPs), Clinical Trial Databases and implement data validation and quality control procedures for individual trials in accordance with Good Clinical Practice (GCP) standards. Main Duties/Responsibilities 1. To oversee the collection and management of data from a variety of routine and research specific sources. 2. Contribute to the design/review of study protocols and provide input to the clinical trial team on data management issues. 3. Attend Trial Management Group (TMG) and Trial Management Team (TMT) meetings; and other trial related meetings as required. 4. Design Case Report Forms (CRFs) and ensure effective management of their generation and quality control. 5. Prepare Case Report Form (CRF) completion instructions and present material for clinical trial activities at investigator meetings and site initiation visits. 6. Train site personnel to help improve the quality of the data being collected (this will involve travel mainly within the UK and Ireland). 7. Provide training to Clinical Trial Administrators (CTAs), Data Processors (DPs) and other CTU staff in study processes, including data entry and patient registration, as required.

2 8. Assist with the development of training programs for Principal Investigators (PIs) and research staff in data management. 9. Define clinical trial database requirements and data validations. 10. Validate and test clinical trial databases including data entry screens and programmed data validations for consistency and accuracy ensuring they meet requirements for reporting of clinical data for the study protocol. 11. Prepare clinical trial documentation including the Data Management Plan (DMP). 12. Generate accurate data clarification requests and track all queries through their resolution and filing in the CRF. 13. Encode all clinical data in agreement with sponsor and statistician. 14. Update tracking systems and create/maintain Trial Master Files (TMFs) and appropriate study documentation. 15. Generate data management status/metrics reports for the clinical trial team and senior management. 16. Prepare study reports and assist the statisticians with data analysis as required, including the review of Clinical Study Reports (CSRs). 17. Ensure appropriate and timely communications with investigative sites in the collection, entry, management, quality control and analysis of data, as required by investigators and sponsors. 18. Ensure that Standard Operating Procedures (SOPs) are followed. 19. Ensure compliance with all ICH/GCP/EU/UK regulations governing clinical trials. 20. Test new processes and systems for the management of clinical trials. 21. Any other duties relevant to this post which may arise and as requested by the NICTU Director. General Responsibilities Employees of the Trust are required to promote and support the mission and vision of the service for which they are responsible and: At all times provide a caring service and to treat those with whom they come into contact in a courteous and respectful manner. Demonstrate their commitment by their regular attendance and the efficient completion of all tasks allocated to them. Comply with the Trust s Smoke Free Policy. Carry out their duties and responsibilities in compliance with the Health and Safety Policies and Statutory Regulations. Adhere to Equality and Good Relations duties throughout the course of their employment. Ensure the ongoing confidence of the public in-service provision. Maintain high standards of personal accountability. Comply with the HSC Code of Conduct.

3 Records Management Used as part of their business within the Belfast Health and Social Care Trust, including patient/client, corporate and administrative records whether paper based or electronic and also including s. All such records are public records and are accessible to the general public, with limited exceptions, under the Freedom of Information Act 2000, the Environment Regulations 2004 and Data Protection Act Employees are required to be conversant with the Belfast Health and Social Care Trust policy and procedure on records management and to seek advice if in doubt. Environmental Cleaning Strategy The Trusts Environmental Cleaning Strategy recognizes the key principle that Cleanliness matters is everyone s responsibility, not just the cleaners Whilst there are staff employed who are responsible for cleaning services, all Trust staff have a responsibility to ensure a clean, comfortable, safe environment for patients, clients, residents, visitors, staff and members of the general public. Infection Prevention and Control The Belfast Trust is committed to reducing Healthcare associated infections (HCAIs) and all staff have a part to play in making this happen. Staff must comply with all policies in relation to Infection Prevention and Control and with ongoing reduction strategies. Standard Infection Prevention and Control Precautions must be used at all times to ensure the safety of patients and staff. This includes:- Cleaning hands either with soap and water or a hand sanitiser at the appropriate times (WHO 5 moments ); Using the correct 7 step hand hygiene technique; Being bare below the elbows when in a clinical environment; Following Trust policies and the Regional Infection Control Manual (found on intranet); Wearing the correct Personal Protective Equipment (PPE); Ensuring correct handling and disposal of waste (including sharps) and laundry; Ensuring all medical devices (equipment) are decontaminated appropriately ie cleaned, disinfected and/or sterilised; Ensuring compliance with High Impact Interventions. Clause: This job description is not meant to be definitive and may be amended to meet the changing needs of the Belfast Health and Social Care Trust.

4 JOB SPECIFICATION POST: LOCATION: Data Manager Northern Ireland Clinical Trials Unit (NICTU) Royal Hospitals, BELFAST ESSENTIAL CRITERIA: 1. Degree or recognised professional qualification or equivalent / higher qualification AND 1 year s experience in a data / information management related role. OR HNC/HND or equivalent /higher qualification AND 2 years experience in a data/ information management related role. OR 4 years experience in a data / information management related role. AND 2. Experience in the use of Microsoft office products including Word, Excel and in particular database systems. 3. Effective planning and organisational skills with an ability to prioritise own workload. 4. Effective communication skills to meet the needs of the post in full. 5. Ability to work as part of a team whilst using own initiative. 6. Ability to identify solutions to problems and implement them effectively. 7. Ability to work to tight timescales whilst meeting targets. DESIRABLE CRITERIA: 1. Experience of working in clinical trials. 2. Knowledge of medical terminology. 3. Project management experience. NOTE: Where educational/professional qualifications form part of the criteria you will be required, if shortlisted for interview, to produce original certificates, and one photocopy of same, issued by the appropriate authority. Only those certificates relevant to the shortlisting criteria should be produced. If educational certificates are not available an original letter and photocopy of same detailing examination results from your school or college will be accepted as an alternative.

5 If successful you will be required to produce documentary evidence that you are legally entitled to live and work in the United Kingdom. This documentation can be a P45, payslip, National Insurance Card or a birth certificate confirming birth in the United Kingdom or the Republic of Ireland. Failure to produce evidence will result in a non appointment.