Overview
As a Principal Clinical Data Science Lead, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence. In this role, you will oversee all aspects of clinical data management for assigned trials, ensuring data integrity, regulatory compliance, and timely deliverables. The role involves collaboration with cross-functional teams, internal departments, and vendors. You will ensure the accuracy and completeness of clinical data for regulatory submissions and support process improvements.
Responsibilities
What you will be doing:
Lead and align data management expectations with CROs, clinical study teams, and stakeholders.
Oversee outsourced data management deliverables according to scope and trial oversight plans.
Ensure timely creation and quality of essential documents (e.g., DMPs, UAT plans, archival packages).
Monitor trial progress against project plans, KPIs, and budgets; make adjustments as needed.
Develop and manage Data Release Plans in line with blinding rules and stakeholder input.
Perform quality control checks for data completeness and accuracy.
Contribute to departmental process improvements and support audits and inspections.
Qualifications
You are:
Bachelor’s or Master’s Degree in Life Sciences, Pharmacy, Mathematics, or related field, or equivalent experience.
Proven experience in Clinical Data Management, including managing CROs and vendors.
Strong knowledge of GCP, CDISC (CDASH, SDTM, ADaM), FDA, and ICH guidelines.
Proficient with clinical study tools (eCRF systems, study progress tracking, metadata repositories).
Excellent attention to detail and analytical problem-solving skills.
Strong interpersonal and communication skills; effective in team and independent settings.
Experience in autoimmune and/or orphan disease trials is a plus.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve prioritized building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers a range of benefits focused on well-being and work-life balance, including:
Various annual leave entitlements
Health insurance options for you and your family
Retirement planning offerings to maximize savings
Global Employee Assistance Programme, TELUS Health, providing 24-hour support from over 80,000 professionals
Life assurance
Flexible country-specific benefits, such as childcare vouchers, bike schemes, gym discounts, travel passes, and health assessments
Visit our careers website to learn more about working at ICON:https://careers.iconplc.com/benefits. ICON is committed to inclusion and diversity, providing an accessible environment for all candidates. We ensure equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. If you need a reasonable accommodation during the application process or to perform job functions, please let us know through the provided form:https://careers.iconplc.com/reasonable-accommodations. We encourage you to apply even if you’re unsure if you meet all requirements—your skills may be exactly what we’re looking for.
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