Senior Data Associate
hace 4 días
Egham
Senior Clinical Data Associate \n Location: Egham, Surrey \n Working Pattern: Permanent, full-time \n Hybrid: 3 days in office / 2 days remote \n Hours: Monday–Friday, 9:00am–5:30pm \n Travel: Some travel required \n Probation: 4 months \n \n About the Company \n A global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic and life-threatening acute disorders, as well as healthcare solutions for the general population. \n \n About the Role \n We are seeking a Senior Clinical Data Associate to support the Data Manager / Senior Data Manager across data management activities for interventional and/or non-interventional clinical studies. \n \n The successful candidate will support end-to-end clinical data management activities from study start-up through to close-out, ensuring data integrity, validity and reliability in accordance with applicable regulations, ICH-GCP requirements, SOPs and study plans. \n As an integral member of the extended study management team, you will contribute to study delivery and broader programme-enabling activities, working cross-functionally with internal teams and external partners. \n This is an opportunity for an experienced Clinical Data Associate to develop towards a Data Manager position, with increasing autonomy and responsibility across clinical data management activities. \n \n Key Responsibilities \n Clinical Study Delivery \n\n • Support the implementation of the Clinical Affairs strategy, helping drive quality, cost, speed and efficiency across clinical study delivery.\n, • Support oversight of data management activities, proactively communicating progress, risks, issues and changes that may impact study quality, timelines or budget.\n, • Provide study-level updates to Data Managers and Clinical Study Leads as required.\n, • Work cross-functionally to ensure transparency, knowledge transfer and alignment across studies.\n\n \n Data Management Activities \n Responsibilities will include, but are not limited to: \n\n • Supporting study start-up activities, including review and development of study documentation and plans such as Statistical Analysis Plans, Data Management Plans and Data Quality Review Plans.\n, • Supporting the design of Case Report Forms, database specifications and database software selection.\n, • Supporting database build and testing, including the design and testing of edit checks.\n, • Supporting risk-based quality management activities.\n, • Supporting study monitoring and risk-based processes to oversee data quality, integrity, participant safety and rights.\n, • Supporting data review and cleaning activities, including query generation and resolution.\n, • Supporting database lock and data transfer processes, including delivery of tables, figures and listings.\n, • Performing ongoing review of data listings, reconciliation outputs and key study metrics to identify data quality trends and potential risks.\n, • Performing clinical study data coding, including MedDRA and WHODrug.\n, • Supporting external data vendor oversight, including EDC service providers, data transfers, reconciliation processes and issue management.\n, • Participating in User Acceptance Testing (UAT) of clinical databases and system enhancements.\n, • Ensuring study files accurately reflect data management activities and that documentation is filed contemporaneously.\n, • Supporting inspection readiness and GCP audits and inspections.\n\n \n Clinical Data & Process Improvement \n\n • Contribute to initiatives supporting study delivery and overall portfolio efficiency.\n, • Support process enhancement and modernisation of clinical trials, including digitalisation, automation and adoption of artificial intelligence tools.\n, • Contribute to the development and implementation of data standards, lessons learned and best practices across clinical programmes.\n, • Support the adoption of new technologies, automation and data visualisation tools to improve data review efficiency.\n, • Support the development of external communications relating to clinical studies.\n, • Contribute to the creation and maintenance of SOPs.\n, • Participate in internal and external meetings and presentations as required.\n\n \n Essential Requirements \n Education \n\n • Degree qualification in Biosciences, Life Sciences, Data Science, Computer Science, Health Sciences or a related discipline.\n\n \n Experience \n\n • Minimum 2 years' experience in Clinical Data Management, Clinical Data Operations, Clinical Research or a related pharmaceutical/CRO environment.\n, • Experience supporting clinical trials across study start-up, study conduct and database lock activities.\n, • Experience working with Electronic Data Capture (EDC) systems.\n\n \n Knowledge \n\n • Proficient in Microsoft Office.\n, • Intermediate Excel skills, including graphing, VLOOKUP/XLOOKUP and Pivot Tables.\n, • Practical experience with GCP and EDC systems.\n, • Working knowledge of ICH-GCP and applicable regulatory requirements, including FDA, EMA and MHRA where applicable.\n, • Understanding of data integrity principles, including ALCOA++.\n, • Understanding of clinical data management processes, including query management, coding, reconciliation and database lock procedures.\n, • Knowledge of CDISC standards, with awareness of SDTM terminology, is desirable.\n, • Understanding of risk-based quality management principles and clinical trial operations.\n\n \n Skills & Competencies \n\n • Strong ability to build and maintain relationships with internal and external stakeholders.\n, • Excellent planning, organisation and follow-up skills.\n, • High attention to detail.\n, • Strong analytical and problem-solving capabilities.\n, • Ability to prioritise competing activities across multiple studies.\n, • Effective verbal and written communication skills.\n, • Ability to work independently while escalating issues appropriately.\n, • Demonstrated ability to work effectively within cross-functional and matrix environments.\n, • Genuine interest in clinical trials and the underlying science.\n\n