Senior Clinical Affairs Specimen Operations Manager Job at Exact Sciences (Madison)

Job Description

The Sr. Clinical Affairs Specimen Operations Manager leads planning and execution of specimen logistics for clinical studies, ensuring that supply, sample handling, and associated data flows reliably support study designs, evidence generation, and portfolio needs. This role leads cross‑functional execution of commercial and pipeline studies, applying operational and scientific expertise to ensure logistical readiness, optimize specimen operations, and deliver clinical programs on time, within budget, and aligned with business objectives. It also provides subject‑matter support to junior team members.

Job Responsibility

Leads operational planning and strategic management of specimen logistics for assigned clinical studies, ensuring supply, collection, shipment, receipt, processing, storage, and reconciliation meet protocol and regulatory standards
Translates study requirements into actionable specimen operations plans, coordinating timelines, deliverables, and execution with clinical, laboratory, program, and external partners
Manage and analyze key specimens and supply performance metrics (e.g., kit usage, sample quality, chain of custody, turnaround times) to identify risks, opportunities, and data‑driven improvements supporting reliable study delivery
Problem-solves and resolves specimen and logistics issues, applying sound judgment to prioritize actions, escalate when needed, and ensure timely resolution in line with established procedures
Lead continuous process improvement, contributing to workflow documentation, standard practices, and initiatives that enhance efficiency, consistency, and scalability across studies
Provides guidance, coaching, and knowledge sharing to less‑experienced team members, serving as a resource on specimen operations processes, tools, and best practices within clinical research
Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
Support and comply with the company’s Quality Management System policies and procedures
Maintain regular and reliable attendance
Ability to act with an inclusion mindset and model these behaviors for the organization
Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day
Ability to travel 10% of working time away from work location, may include overnight/weekend

Requirements

Bachelor’s degree in health or life sciences, supply chain, engineering, or a related field relevant to specimen logistics or clinical operations
7+ years of experience in clinical trial operations, specimen or sample management, logistics, supply chain, or related operational support of clinical studies
Demonstrated experience coordinating cross‑functional activities, applying working knowledge of project management principles to support execution across multiple studies or initiatives

What we offer

Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
Retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Bonus eligibility

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Senior Clinical Affairs Specimen Operations Manager

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