Biosample Operations Specialist

Icon • Cambridge, MA

88d • Remote

About The Position

The Biosample Operations Specialist is responsible for overseeing the biomarker laboratory samples for the client's clinical trials across the chain of custody from research site to the analysis laboratory. This role supports Study Teams across the portfolio of therapeutic areas.

Requirements

• Bachelor's degree in Biochemistry, Chemistry, Biology, Immunology, Medical Technology or related life sciences field preferred.
• Experience working in a laboratory, research site and/or clinical trial management role at a biopharma company.
• Working knowledge of FDA & ICH/GCP regulations.
• Proven critical reasoning and problem solving skills.
• Ability to oversee sample management activities across multiple projects, while maintaining electronic tracking system.
• Excellent written, organizational and interpersonal communication skills necessary to collaborate and interface with outside vendors, consultants, and internal study team members (scientists, clinicians, clinical trial managers).
• Proficiency in Microsoft Office Applications including Excel, Word and PowerPoint.

Responsibilities

• Accountable for planning, coordinating and overseeing all operational activities required to manage the lifecycle of biomarker samples (oversight of sample collection at site, shipment to vendor for testing/processing, analysis and final sample disposition) ensuring sample integrity and GCP compliance throughout the process.
• Collaborates with study teams and biomarker scientists to develop biological sample management plans in concurrence with sites, and central and specialized laboratories for all biomarker samples.
• Reviews clinical study protocols, informed consent forms, laboratory documents, case report forms and service provider laboratory scope of work documents for sample handling details.
• Interfaces with laboratory personnel, sample processing and other vendors to ensure proper shipment and receipt of samples, responding to issues as needed to ensure study objectives for clinical biomarkers are met.
• Works closely with study teams to manage monitoring of appropriate patient consent for all biosample collection and testing.
• Ensures compliance with European GDPR requirements for personal information transmitted with biosamples.

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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree