Senior Manager, Biosample Operations - Remote

Overview

The Senior Manager, Biosample Operations 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 the requirements of quality, and ethical and regulatory standards, including ICH/GCP/GLP.
• Accountable for the implementation, execution and oversight of sample collection, processing, storage, and reconciliation, with the goal of maximizing sample accrual and quality.
• Independently review clinical study protocols, informed consents, laboratory documents, case report forms, laboratory scopes of work, laboratory budgets and invoices.
• Review and file necessary vendor laboratory documents for the Trial Master File (TMF) as applicable.
• Accountable for planning, coordinating, and overseeing 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 for assigned clinical trials.
• 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 and/or Clinical Operations functions.
• Mentor junior Biosample Managers and Biosample Specialists.

Requirements

• Bachelor’s degree, preferably in a scientific or healthcare field or equivalent combined education.
• 7+ years of clinical trial management experience preferred.
• 4+ years of Biosample Operations experience required.
• Advanced understanding of clinical trial processes from study start-up through study closure.
• Excellent knowledge of ICH GCP and GLP guidelines.
• Proven ability to independently establish priorities and work with urgency.
• Advanced project management skills with the ability to identify risks and issues.
• Strong interpersonal and negotiation skills as well as strong verbal and written communication.
• Proficiency with Microsoft Office.
• Proven problem solving and decision-making skills.
• Ability and willingness to travel ~10% (domestic/international).

Benefits

• Competitive market-based salary.
• Opportunity to participate in stock programs.
• Performance-based bonus.
• Comprehensive benefits package.