Data Specialist Senior Associate in Egham, Surrey

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.

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.

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.

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.

Key Responsibilities:

• Support the implementation of the Clinical Affairs strategy, helping drive quality, cost, speed and efficiency across clinical study delivery.
• Support oversight of data management activities, proactively communicating progress, risks, issues and changes that may impact study quality, timelines or budget.
• Provide study-level updates to Data Managers and Clinical Study Leads as required.

Data Management Activities:

• 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.
• Supporting the design of Case Report Forms, database specifications and database software selection.
• Supporting database build and testing, including the design and testing of edit checks.
• Supporting risk-based quality management activities.
• Supporting study monitoring and risk-based processes to oversee data quality, integrity, participant safety and rights.
• Supporting data review and cleaning activities, including query generation and resolution.
• Supporting database lock and data transfer processes, including delivery of tables, figures and listings.
• Performing ongoing review of data listings, reconciliation outputs and key study metrics to identify data quality trends and potential risks.
• Performing clinical study data coding, including MedDRA and WHODrug.
• Supporting external data vendor oversight, including EDC service providers, data transfers, reconciliation processes and issue management.
• Participating in User Acceptance Testing (UAT) of clinical databases and system enhancements.
• Ensuring study files accurately reflect data management activities and that documentation is filed contemporaneously.
• Supporting inspection readiness and GCP audits and inspections.

Clinical Data & Process Improvement:

• Support process enhancement and modernisation of clinical trials, including digitalisation, automation and adoption of artificial intelligence tools.
• Contribute to the development and implementation of data standards, lessons learned and best practices across clinical programmes.
• Support the adoption of new technologies, automation and data visualisation tools to improve data review efficiency.

Qualifications:

• Degree qualification in Biosciences, Life Sciences, Data Science, Computer Science, Health Sciences or a related discipline.
• Minimum 2 years' experience in Clinical Data Management, Clinical Data Operations, Clinical Research or a related pharmaceutical/CRO environment.
• Experience supporting clinical trials across study start-up, study conduct and database lock activities.
• Experience working with Electronic Data Capture (EDC) systems.
• Proficient in Microsoft Office.
• Intermediate Excel skills, including graphing, VLOOKUP/XLOOKUP and Pivot Tables.
• Working knowledge of ICH-GCP and applicable regulatory requirements, including FDA, EMA and MHRA where applicable.
• Understanding of data integrity principles, including ALCOA++.
• Understanding of clinical data management processes, including query management, coding, reconciliation and database lock procedures.
• Understanding of risk-based quality management principles and clinical trial operations.
• Excellent planning, organisation and follow-up skills.