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Senior Clinical Data Manager

ICON

About this role

Senior Clinical Data Manager

What You Will Be Doing

  • Serve as the primary Data Management lead for complex global studies and drive delivery from start-up through database lock and close-out.

  • Set the study Data Management approach, lead cross-functional data review and proactively manage risks, issues and escalation pathways.

  • Oversee complex external data reconciliation and vendor performance across eCOA, PK, biomarker, local laboratory, safety and other study data.

  • Author, review and provide subject matter expertise for key Data Management documentation, EDC UAT and data validation activities.

  • Drive database lock readiness, protocol deviation and SAE reconciliation, quality metrics and inspection preparedness.

  • Act as a Data Management subject matter expert, providing guidance and mentoring to supporting FSP colleagues.

You will have/be:

  • Bachelor's degree in a Life Sciences related discipline.

  • 7+ years of Clinical Data Management experience within a CRO, pharmaceutical or biotechnology environment.

  • Proven experience as the primary Data Management lead for complex global clinical studies.

  • Strong expertise in EDC review, complex external data reconciliation, vendor oversight, study documentation and database lock.

  • Demonstrated stakeholder leadership, proactive risk management and mentoring experience.

  • Veeva EDC experience is desirable but not essential.

ICON benefits

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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