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Senior Data Associate
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Senior Clinical Data Associate
Location: Egham, Surrey
Working Pattern: Permanent, full-time
Hybrid: 3 days in office / 2 days remote
Hours: Monday–Friday, 9:00am–5:30pm
Travel: Some travel required
Probation: 4 months
About the Company
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.
About the Role
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. 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. 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
Clinical Study Delivery
- 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.
- Work cross-functionally to ensure transparency, knowledge transfer and alignment across studies.
Data Management Activities
Responsibilities will include, but are not limited to:
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- 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
- Contribute to initiatives supporting study delivery and overall portfolio efficiency.
- 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.
- Support the development of external communications relating to clinical studies.
- Contribute to the creation and maintenance of SOPs.
- Participate in internal and external meetings and presentations as required.
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Essential Requirements
Education
- Degree qualification in Biosciences, Life Sciences, Data Science, Computer Science, Health Sciences or a related discipline.
Experience
- 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.
Knowledge
- Proficient in Microsoft Office.
- Intermediate Excel skills, including graphing, VLOOKUP/XLOOKUP and Pivot Tables.
- Practical experience with GCP and EDC systems.
- 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.
- Knowledge of CDISC standards, with awareness of SDTM terminology, is desirable.
- Understanding of risk-based quality management principles and clinical trial operations.
Skills & Competencies
- Strong ability to build and maintain relationships with internal and external stakeholders.
- Excellent planning, organisation and follow-up skills.
- High attention to detail.
- Strong analytical and problem-solving capabilities.
- Ability to prioritise competing activities across multiple studies.
- Effective verbal and written communication skills.
- Ability to work independently while escalating issues appropriately.
- Demonstrated ability to work effectively within cross-functional and matrix environments.
- Genuine interest in clinical trials and the underlying science.
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