Advisor, Bio Sample Operations – DMPK

Eli Lilly and Company

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

Posted 11/5/2026full-timeRemote • United StatesSeniorLead💰 $153,000 - $246,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in bio sample operations management, including the end-to-end lifecycle of clinical bio samples, compliance with GCP regulations, and effective project management across cross-functional teams. Proficient in utilizing LIMS and clinical trial management systems to ensure sample traceability and operational excellence.

Highest-signal resume keywords

Bio Sample Lifecycle ManagementClinical Trial OperationsProject Management SkillsGCP Principles KnowledgeLIMS Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Bio Sample OperationsBiospecimen ManagementLaboratory OperationsSample TrackingReconciliationClinical ResearchQuality StandardsMulti-Country Sample LogisticsOperational PlansProtocol Translation

Soft Skills

Strong CommunicationOrganization SkillsStakeholder ManagementProblem-Solving Skills

Tools & Technologies

LIMSClinical Trial Management SystemsSample Management Systems

Industry Keywords

PharmaceuticalBiotechnologyCROClinical ResearchGCP Regulations

About the role

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

Requirements

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, with the 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

Benefits

Comp & perks

Company bonus depending, in part, on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical benefits
Dental benefits
Vision benefits
Prescription drug benefits
Healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Employee assistance program
Fitness benefits
Employee clubs and activities