Senior Manager Biosample Operations Lead

BIOSAMPLE OPERATIONS LEAD ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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. #LI-MC1

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include: Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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

Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request  here .

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