Project Manager - Biospecimen

Thermo Fisher Scientific - Trenton, NJ

Full-time - Mid Level

Trenton, NJ

10,001+ employees

Computer and Electronic Product Manufacturing

About the position

The Project Manager - Biospecimen at Thermo Fisher Scientific is responsible for overseeing the complete lifecycle of biospecimens collected for clinical studies. This role involves working closely with Clinical Teams to develop and implement biospecimen management plans for client-sponsored clinical trials. The Project Manager will provide innovative solutions to ensure timely specimen data delivery, enabling quick decision-making and maintaining the client's competitive advantage. The position requires independent management of biospecimen strategies and collaboration across various teams and clients.

Responsibilities

• Oversee and manage the complete lifecycle of biospecimens collected for clinical studies with minimal supervision.
• Serve as a core Clinical Team member responsible for shipping/sample movement and management, including requests, queries, and inventory reports.
• Follow up on active issues with vendors and prepare sample management-related reports.
• Review and prepare tracking activities such as vendor manifests/inventories and tissue/blood match pairing.
• Independently review clinical study protocols and provide feedback on vendor statements of work and biospecimen relevant sections.
• Perform routine vendor management responsibilities and access necessary vendor/system inventory files for specimen tracking.
• Create biospecimen trackers using various tracking tools (MS Excel, Spotfire, Tableau, or Polaris) with support.
• Identify biospecimen-related risks and propose mitigation strategies as needed.
• Support the Critical to Quality (C2Q) process with guidance, if needed.
• Maintain an intermediate working knowledge of compound and study-related biospecimen requirements.

Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• 3+ years of previous experience in clinical trial management or related fields.
• Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management, and regulatory issues.
• Demonstrated clinical trial experience in healthcare/medical/laboratory settings.
• Ability to develop skills for stakeholder management, including conflict and change management.

Nice-to-haves

• Experience in biospecimen life-cycle/operations, compliance, management, and vendor management.
• Knowledge of the drug discovery or developmental process.
• Experience with vendor management in Central Labs, Bioanalytical, Biomarker, CROs, or Biospecimen Storage Vendors.

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare benefits
• Range of employee benefits
• Career and development prospects
• Innovative company culture