Senior Data Manager

7 days ago

Slough Berkshire, United Kingdom EPM Scientific Full time

About the Company

A global specialty pharmaceutical group focused on developing and commercializing treatments for patients with genetic, metabolic, systemic, and life-threatening acute disorders, as well as healthcare solutions for the general population.

About the Role

The Senior Data Manager will oversee data management activities for interventional and non-interventional clinical studies, ensuring compliance with applicable regulations, ICH/GCP guidelines, Standard Operating Procedures (SOPs), and study plans across assigned clinical programs. This role is crucial in managing end-to-end data management activities from study initiation to closeout, maintaining a focus on data integrity, validity, and reliability to support study delivery according to strategic timelines and budgets.

Responsibilities

Based in Egham, the Senior Data Manager is expected to:

Clinical Study Delivery

  • 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.
  • Maintain oversight of data management status and proactively communicate progress, risks, issues, or changes that may affect quality, timelines, or budget to the Clinical Study Lead.
  • Collaborate cross-functionally to ensure transparency, knowledge transfer, and alignment within studies.
  • Focus areas include:
  • Assisting in implementing Quality by Design principles during protocol development.
  • Managing start-up activities, including reviewing and developing study documentation (e.g., Statistical Analysis Plan, Data Management Plan), designing Case Report Forms, and conducting database selection, building, and testing.
  • Overseeing study monitoring and implementing risk-based quality management processes to ensure data quality, integrity, and participant safety.
  • Managing database lock and transfer processes and supporting the delivery of tables, figures, and listings.
  • Ensuring study files accurately reflect data management activities and that documents are filed contemporaneously.
  • Supporting selection and oversight of service providers, monitoring budgets, and managing performance.
  • Ensure inspection readiness for studies and support GCP audits and inspections.

Enabling Activities

  • Engage in initiatives that enhance the efficiency of programs and studies, including process improvements, digital integration, and knowledge transfer.

People Management

  • 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.
  • Assist in training relevant staff as necessary.

Other Responsibilities

  • Support the development of external communications related to clinical studies.
  • Attend conferences and external events.
  • Conduct internal training sessions when required.

Essential 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.
  • Strong knowledge of international clinical research regulations and ICH/GCP requirements.
  • Experience with clinical trial databases, data flow management, and eCRF design.
  • Excellent written and verbal communication skills.
  • Strong project management abilities.
  • Independence and the ability to lead a team effectively.
  • Observational and analytical skills.
  • Good time management skills with the ability to meet tight deadlines.
  • Ability to quickly problem-solve and make decisions.

What’s on Offer

  • Competitive salary with benefits.
  • An opportunity to contribute to work that directly benefits healthcare and improves lives.
  • Hands-on experience with high commercial exposure.
  • Collaboration with world-leading scientific experts.
  • A chance to work with dedicated colleagues in a fast-growing company focused on cutting-edge science and commercial success.

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