Advisor, Bio Sample Operations – DMPK

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the bio sample operations throughout clinical studies, from initiation to database lock, closing out, and final sample management.

• Convert protocol and laboratory specifications into tailored bio sample strategies, timelines, workflows, manuals, collection materials, and operational plans for each study.

• Supervise the complete bio sample lifecycle, encompassing collection, processing, labeling, shipment, receipt, storage, analysis, reconciliation, retention, and disposal.

• Coordinate cross-functional teams and external partners to ensure bio sample activities are executed on schedule, within budget, and meet quality standards.

• Oversee central and specialty laboratories, biorepositories, couriers, CROs, and other vendors, managing contracts, deliverables, performance metrics, KPIs, and SLAs.

• Ensure sample traceability, maintain chain of custody, verify inventory accuracy, and ensure alignment across clinical, laboratory, and sample management systems.

• Identify, address, and escalate operational and quality issues, including shipment challenges, missing samples, discrepancies, deviations, CAPAs, and findings from audits or inspections.

• Ensure adherence to protocols, GCP regulations, internal SOPs, quality standards, and regulatory requirements, while enhancing processes through standardized tools, governance, metrics, and lessons learned.

⛳️ Requirements

• A Bachelor's degree in life sciences, biotechnology, pharmacy, healthcare, clinical research, or a related field.

• Over 8 years of relevant experience in pharmaceutical, biotechnology, CRO, or clinical research settings.

• Proficiency in clinical trial operations, biospecimen management, laboratory or biomarker operations, and the clinical bio sample lifecycle management.

• Demonstrated project management capabilities, with the capacity to juggle multiple complex priorities within a matrixed organization.

• Experience collaborating cross-functionally and managing central and specialty laboratory vendors and other international partners.

• Strong understanding of GCP principles, clinical research quality standards, global trials, and multi-country sample logistics.

• Familiarity with LIMS, bio sample or clinical trial management systems, sample tracking, reconciliation, and the integration of laboratory and clinical data.

• Excellent communication, organizational, stakeholder management, and problem-solving abilities.

• Willingness to travel approximately 10%-20%, including visits to CROs and external partners as necessary.

🏝️ Benefits

• Company bonus based on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• Prescription drug benefits.

• Flexible spending accounts for healthcare and/or dependent day care.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Employee assistance program.

• Fitness benefits.

• Opportunities to participate in employee clubs and activities.