BIOSAMPLE OPERATIONS LEAD

Job title: BIOSAMPLE OPERATIONS LEAD

About the Role BIOSAMPLE OPERATIONS LEAD will own end-to-end biosample operations across assigned studies/programs—from operational feasibility, vendor selection, to analysis and data delivery. You will be the primary point of contact for the Study Team on biosample operations including biomarker and bioanalytical activities, ensuring samples are collected, processed, and delivered to the highest quality and regulatory standards while balancing patient burden and operational efficiency.

What You'll Do

• Provides strategic and expert input for the operational feasibility, implementation and execution of the biosample operations activities in assigned clinical studies/programs.
• Manages biosample management activities in clinical studies with low to moderate complexity, risk, impact and reach.
• Accountable for planning, implementation and execution of biosample operations activities, ensuring proactive risks and issues management and alignment with overall clinical study timelines in assigned clinical studies.
• Owns biosample operations plan and is responsible for its maintenance and adjustments during clinical study conduct.
• Leads cross-functional biosample operations team and manage team meetings to review status of biosample operations activities, discuss risks/issues and agree on appropriate mitigation/contingency.
• Acts as the single point of contact in Study Team on biosample operations related aspects (including biomarker and bioanalytical activities). Ensures timely status updates and escalation of risks/issues to the clinical Study Team.
• Contributes to central lab or assay lab vendor selection and qualification.
• Oversees Central lab set-up, kit management, and ongoing study level vendor performance.
• Manages CRO and central lab interfaces to ensure cross-functional alignment on deliverables.
• Maintains a patient focus approach while delivering the complex requirements of a clinical study, balancing patient burden, sampling requirements, the complexity of collection and the cost implications.
• Responsible for overseeing the biosample lifecycle and compliance to ensure that the biosamples are collected, processed, analysed and stored with the highest degree of quality and according to applicable regulations.
• Reviews and provides input to protocols, ICFs, lab manuals, and regulatory submissions.
• Leads budget planning & forecasting for biosample activities of assigned studies.
• Ensures all activities comply with ICH-GCP, GCLP, biobanking policies, and applicable ethical standards.
• Leads audit and inspection readiness; act as interviewee and prepare regulatory responses.
• Drives process improvements and leads or contributes to functional excellence initiatives within department and broader organization.
• Acts as a subject matter expert within the team and beyond.

Compensation & Benefits

• In addition to your competitive salary, ICON offers a range of additional benefits.
• 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.
• Visit our careers site to read more about the benefits ICON offers.