Data Manager -B4

Please refer to the full job descriptiojn & person spec. As part of the team you will have the opportunity for personal and professional development and ongoing education with access to the Kent, Surrey and Sussex Clinical Research Delivery Network. Operating strictly within ICH/GCP guidelines, Research Governance Standards, and Trust Data Protection policies, you will maintain meticulous filing systems, prioritise your workload to hit critical trial deadlines, and mentor data assistants as needed to drive network objectives forward. Potential candidates should be able to demonstrate: A good understanding of data collection or clinical audit Good interpersonal and communication skills. 1. Data Management To be responsible for the input of clinical and other data necessary for clinical trial purposes: - Checking all data is accurately populated, ensuring all empty data fields are completed to ensure correct analysis of trial - Responsible for forwarding completed data and data queries to trials unit (sponsor) - Maintain spread sheets/database on patient recruitment - Maintenance of robust systems to track and monitor patient and financial progress through clinical trials. To be responsible for the electronic or paper entry of the Case Report Forms (CRFs) in line with the agreed timelines within the Clinical Trial Agreement (CTA) for commercial sponsors and local SOPs for Academic studies To ensure all patients questionnaire data fields are populated, to enable electronic capture or the hard copies to be forwarded to the sponsor as required by the research protocol Priorities workload to ensure specific deadlines, expected timelines and clinical importance are achieved. To be responsible for liaising with Clinical Trials Units (Sponsor) regarding data queries and for checking/resolving data queries To be responsible for liaising with commercial trial sponsors to ensure complex data issues are resolved To have an overall understanding of the activities associated with each trial that is allocated to the research team and financial implications To utilise the Trusts Patient Administration System, Telepath, CRIS (Clinical radiology Information System) and other information systems. To produce reports of the numbers of patients in follow-up as requested by the other member of the Research Team To comply with the Trusts policy on Data Protection, Confidentiality and security. To work to International Conference on Harmonisation Good Clinical Practice (ICH/GCP) and Research Governance Standard The creation of source data worksheets to reflect all data required at each study visit. Create patient pathways with the input from the wider research team for all new studies. Assess CRFs pre study initiation to ensure accurate time estimates are used to assist with study set up. 2. Communication To work closely with the Research Nurses/practitioners and clinicians to ensure that all data are captured for patients on clinical trials and question missing fields. To establish communication lines and understand process with medical records department, radiology and pathology in order to obtain relevant medical records for those patients on clinical trials To attend Research related meetings and to contribute to the development of the Research Network. To deal sensitively and in a professional manner with patients in person and on the telephone To prepare for and attend commercial and NCRI trial sponsor monitoring visits or audit inspections by regulatory authorities 3. Other Duties Mentoring of data assistant where relevant To remain in contact with local and national organisations in order to keep up to date with relevant trials and data management issues Attend the National Institute for Health Research training programmes and other relevant education and training days/programmes as appropriate To work effectively to deadlines and prioritise work appropriately To organise transportation of clinical samples in a timely manner and liaise with couriers to arrange transportation of clinical specimens in the absence of the biological specimen co-ordinator. Uploading of digital images required by sponsors.