At a Glance
- Tasks: Support clinical data management for exciting studies and ensure data integrity.
- Company: Global specialty pharmaceutical group focused on innovative healthcare solutions.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Great career progression towards a Data Manager role.
- Why this job: Join a dynamic team and make a real impact in patient care.
- Qualifications: Experience in clinical data management and strong communication skills.
The predicted salary is between 51750 - 63250 £ per year.
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
- 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:
- 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.
Senior Data Associate in Surrey employer: Meet Life Sciences
As a Market Access Consultant with our client, you will be part of a dynamic team that values innovation and collaboration in the evolving healthcare landscape. The company offers a supportive work culture with opportunities for professional growth, including mentoring junior team members and leading impactful projects. With competitive compensation, hybrid working options, and comprehensive benefits, this role provides a meaningful opportunity to contribute to the expansion of European Value & Access capabilities while enjoying a fulfilling work-life balance.
