Senior Data Manager

5 days ago

Slough, Slough, United Kingdom EPM Scientific Full time
Senior Data Manager Job Description

EPM Scientific is seeking a highly skilled Senior Data Manager to join our team in Egham. As a key member of our Clinical Affairs team, you will be responsible for overseeing data management activities for interventional and non-interventional clinical studies.

Key Responsibilities:
  • Ensure compliance with applicable regulations, ICH/GCP guidelines, Standard Operating Procedures (SOPs), and study plans across assigned clinical programs.
  • Manage end-to-end data management activities from study initiation to closeout, maintaining a focus on data integrity, validity, and reliability.
  • Support the Director of Global Clinical Affairs in implementing a vision for Clinical Affairs that enhances the quality, cost, speed, and efficiency of clinical study delivery.
  • Proactively communicate progress, risks, issues, or changes that may affect quality, timelines, or budget to the Clinical Study Lead.
  • Assist in implementing Quality by Design principles during protocol development.
  • Oversee study monitoring and implement risk-based quality management processes to ensure data quality, integrity, and participant safety.
  • Manage database lock and transfer processes and support the delivery of tables, figures, and listings.
  • Ensure study files accurately reflect data management activities and that documents are filed contemporaneously.
  • Support selection and oversight of service providers, monitoring budgets, and managing performance.
  • Ensure inspection readiness for studies and support GCP audits and inspections.
  • Engage in initiatives that enhance the efficiency of programs and studies, including process improvements, digital integration, and knowledge transfer.
  • Provide leadership, support, feedback, coaching, and mentoring to members of the Clinical Affairs team.
  • May supervise direct reports within the Data Science team, as agreed with the Clinical Program Lead and Director of Global Clinical Affairs.
Requirements:
  • Bachelor's degree or equivalent experience in Mathematics, Science, or a related field.
  • Proven experience in the pharmaceutical or biotech industry, specifically in Clinical Research and/or Clinical Data Management.
  • Experience with clinical trial databases, data flow management, and eCRF design.
  • Strong project management abilities.

EPM Scientific offers a competitive salary with benefits, hands-on experience with high commercial exposure, collaboration with world-leading scientific experts, and a chance to work with dedicated colleagues in a fast-growing company focused on cutting-edge science and commercial success.

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