Biosampling Project Manager

Biosampling Project Manager

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Biosampling Project Manager (BPM) , you will play a critical role in ensuring the successful implementation of biosample and laboratory strategies for clinical studies

What You Will Do:

You will be responsible for administering biosampling activities, managing laboratory vendors, and ensuring the timely delivery of high-quality samples and data.

Key responsibilities include:

• Implement biosample and laboratory strategies for assigned clinical studies, ensuring timely delivery and optimal quality.
• Provide study-level oversight of laboratories/vendors involved in biosampling activities and analyses; contribute to laboratory selection processes.
• Responsible to manage operations for biosampling activities, ensuring timely data delivery in collaboration with stakeholders during study conduct.
• Provide regular study-level updates to Biosampling Project Leaders (BPLs), Study Management Teams (SMTs), and other stakeholders.
• Deploy sample management strategies and oversee laboratory activities, including technical qualification, sample analysis plans, validations, and analytical reports.
• Contribute to site-level feasibility and selection processes related to sample collection, processing, and shipping requirements.
• Responsible to provide and/or review sample handling training and relevant reference materials for clinical studies with the scientific leads, third parties and BPL.
• Provide input to protocol and informed consent design to ensure logistical feasibility and compliance with regulatory, legal, and ethical guidelines.
• Ensure alignment of biosampling set up with Dx Operations, for assays overseen by the DX groups in the RU
• Ensure appropriate sample quality, define corrective actions for study issues, and escalate issues when necessary
• Contribute to functional process and system improvements to drive operational excellence

Your Profile:

You will have solid clinical trial management experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

• Experience in clinical trial specimen management, including collection/processing of diverse sample types, laboratory management, LIMS, and project management.
• Knowledge of the clinical development process, GxP, and global regulatory requirements.
• Strong communication, interpersonal, and matrix working skills.
• Self-motivated and able to work independently, with a proactive attitude and ability to collaborate effectively within multidisciplinary teams.
• Demonstrated knowledge of global regulatory requirements for sample analysis, including sample exportation.
• Bachelor’s degree in a science or health-related discipline
• Experience with validation and implementation of biomarkers.

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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.

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