Senior Manager, Biosample Operations - Contractor - Remote

Overview

The Senior Manager, Biosample Operations Contractor will be responsible for planning, implementing, managing, and driving biological sample logistics across Phase I-IV Clinical Trials. This role is an essential member of the Clinical Operations function and must be able to collaborate with the cross-functional teams both internal and external.

In Short

• Expertly advise on and deliver the sample strategy for clinical trials within quality, ethical, and regulatory standards.
• Accountable for the implementation and oversight of sample collection, processing, storage, and reconciliation.
• Independently review clinical study protocols and laboratory documents.
• Review and file vendor laboratory documents for the Trial Master File.
• Oversee all operational activities required to manage the lifecycle of clinical trial samples.
• Be the primary point of contact for study team related to sample operations.
• Collaborate with cross-functional study teams to ensure delivery of samples per project milestones.
• Track and report on sample management status and address issues proactively.
• Lead innovation and process improvement activities for Biosample Operations.
• Mentor junior Biosample Managers and Specialists.

Requirements

• Bachelor’s degree in a scientific or healthcare field or equivalent education.
• 7+ years of clinical trial management experience preferred.
• 4+ years of Biosample Operations experience required.
• Advanced understanding of clinical trial processes related to sample management.
• Excellent knowledge of ICH GCP and GLP guidelines.
• Proven ability to establish priorities and work collaboratively.
• Advanced project management skills with risk identification capabilities.
• Strong interpersonal and negotiation skills.
• Proficiency with Microsoft Office.
• Ability and willingness to travel ~10% (domestic/international).

Benefits

• Flexible work environment with remote options.
• Opportunity to lead and innovate in clinical operations.
• Mentorship opportunities for career development.
• Engagement with cross-functional teams.
• Contribution to impactful clinical trial outcomes.