Advisor, Bio Sample Operations – DMPK

. Lead bio sample operations across clinical studies from start-up through database lock, closeout and final sample disposition .

Posted 10/24/2026full-timeRemote • Massachusetts • United StatesSeniorLead💰 $153,000 - $268,400 per yearWebsite

Key responsibilities & impact

Lead bio sample operations across clinical studies from start-up through database lock, closeout and final sample disposition
Translate protocol and laboratory requirements into study-specific bio sample strategies, timelines, workflows, manuals, collection materials and operational plans
Oversee the end-to-end bio sample lifecycle, including collection, processing, labeling, shipment, receipt, storage, analysis, reconciliation, retention and disposition
Coordinate cross-functional teams and external partners to deliver bio sample activities on time, within budget and to required quality standards
Manage central and specialty laboratories, biorepositories, couriers, CROs and other vendors, including contracts, deliverables, performance, KPIs and SLAs
Maintain sample traceability, chain of custody, inventory accuracy and alignment across clinical, laboratory and sample-management systems
Identify, resolve and escalate operational and quality issues, including shipment problems, missing samples, discrepancies, deviations, CAPAs and audit or inspection findings
Ensure compliance with protocols, GCP regulations, internal SOPs, quality standards and regulatory requirements while improving processes through standardized tools, governance, metrics and lessons learned
Partner with Clinical Operations, Bioanalytical Sciences, Quality, Regulatory and external vendors in a cross-functional global environment

What you’ll need

Bachelor's degree in life sciences, biotechnology, pharmacy, healthcare, clinical research or related discipline
8+ years of relevant experience in pharmaceutical, biotechnology, CRO or clinical research environments
Experience in clinical trial operations, biospecimen management, laboratory or biomarker operations and clinical bio sample lifecycle management
Proven project management skills and ability to balance multiple complex priorities in a matrixed organization
Experience working cross-functionally and managing central and specialty laboratory vendors and other international partners
Strong knowledge of GCP principles, clinical research quality standards, global trials, and multi-country sample logistics
Experience with LIMS, bio sample or clinical trial management systems, sample tracking, reconciliation, and integration of laboratory and clinical data
Strong communication, organization, stakeholder management, and problem-solving skills
Ability to travel approximately 10%-20%, including visits to CROs and external partners as needed

Comp & perks

Company bonus depending in part on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical, dental, vision and prescription drug benefits
Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
Employee resource groups and support networks