Senior Manager Biosample Operations Lead

BIOSAMPLE OPERATIONS LEAD

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

This role will own end-to-end biosample operations across assigned studies/programs — from operational feasibility, vendor selection, execution of biosample operations activities  through analysis and data delivery. As the primary point of contact for the Study Team on all biosample operations activities, including biomarker and bioanalytical operational activities, you will ensure every biosample is collected, processed, and delivered to the highest quality and regulatory standard, while keeping a sharp focus on patient burden and operational efficiency.

What You Will 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 (POC) 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.

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What ICON can offer you:
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.

Visit our careers site to read more about the benefits ICON offers.

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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply