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Senior Data Manager

3 months ago

London UK, UK, United Kingdom EPM Scientific Full time

Position Title: Senior Data Manager

Reporting To: Director, Global Clinical Affairs

Position Type: Permanent Full-Time (5 days per week), with a 6-month probation period

Location: Surrey

Working Hours: 9:00 AM to 5:30 PM, Monday to Friday, with a hybrid model (three days in-office, two days remote)

Travel: Some travel required


ABOUT THE COMPANY

This global specialty pharmaceutical group is 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 is responsible for overseeing data management activities related to interventional and/or non-interventional clinical studies. This role ensures compliance with applicable regulations, ICH/GCP guidelines, Standard Operating Procedures (SOPs), and study plans. The Senior Data Manager plays a critical role in maintaining data integrity, validity, and reliability throughout the study lifecycle, from start-up to close-out, to support the successful delivery of clinical programs within specified timelines and budgets.


KEY RESPONSIBILITIES

The Senior Data Manager will:

Clinical Study Delivery:

  • Support the Director, Global Clinical Affairs in driving the quality, cost, speed, and efficiency of clinical study delivery.
  • Maintain an overview of data management-related status and issues, proactively communicating progress, risks, and changes to the Clinical Study Lead that may impact quality, timelines, or budget.
  • Engage cross-functionally to ensure transparency, knowledge transfer, and alignment within the study teams.
  • Oversee and execute various aspects of study delivery, including protocol development, start-up activities, study monitoring, data review, and study analysis.
  • Ensure that all study files accurately reflect data management activities and are filed contemporaneously.
  • Manage service providers, including selection, budget monitoring, and performance oversight.
  • Ensure inspection readiness and support GCP audits and inspections.

Clinical Study Enabling Activities:

  • Participate in and implement activities that enhance program and study delivery, including process improvements, digital integration, and knowledge transfer.

People Management:

  • Provide leadership, support, feedback, and mentoring to other members of the Clinical Affairs team.
  • May manage direct reports within the Data Science team, as agreed with the Clinical Program Lead and Director, Global Clinical Affairs.
  • Assist in training relevant staff as needed.

Other Responsibilities:

  • Support the development of external communications related to clinical studies.
  • Attend conferences and external events as a representative of the company.
  • Conduct internal training sessions, where required.


ESSENTIAL REQUIREMENTS

  • Bachelor’s degree or equivalent experience in Mathematics, Science, or a related field.
  • Proven experience in the pharmaceutical or biotech industry within Clinical Research and/or Clinical Data Management.
  • Strong knowledge of international clinical research regulations and ICH/GCP guidelines.
  • Experience with clinical trial databases and applications, clinical data flow, data review, and eCRF design.
  • Excellent communication skills, both written and verbal.
  • Strong project management skills.
  • Ability to lead a team effectively and work independently.
  • Strong observational, analytical, and problem-solving skills.
  • Good time management skills and the ability to meet tight deadlines.


WHAT’S ON OFFER

  • Competitive salary with benefits.
  • Opportunity to contribute to work that directly benefits healthcare and improves lives.
  • Hands-on role with significant commercial exposure.
  • Chance to work alongside world-leading scientific experts.
  • Collaborative environment with highly talented colleagues in a fast-growing company that combines cutting-edge science with commercial delivery.