Advisor, Bio Sample Operations – DMPK

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

📋 Description

• Lead operations for bio samples throughout clinical studies, encompassing start-up, database lock, closeout, and final disposition of samples.

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

• Supervise the complete bio sample lifecycle, which includes collection, processing, labeling, shipment, receipt, storage, analysis, reconciliation, retention, and final disposition.

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

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

• Ensure sample traceability, maintain chain of custody, and ensure inventory accuracy while aligning clinical, laboratory, and sample-management systems.

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

• Guarantee adherence to protocols, GCP regulations, internal SOPs, quality standards, and regulatory requirements while enhancing processes through standardized tools, governance, metrics, and insights gained from experiences.

• Collaborate with Clinical Operations, Bioanalytical Sciences, Quality, Regulatory teams, and external vendors in a globally integrated environment.

⛳️ Requirements

• 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 sectors.

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

• Demonstrated project management capabilities and the ability to prioritize multiple complex tasks within a matrixed organization.

• Experience in cross-functional collaboration and managing both central and specialty laboratory vendors as well as other international partners.

• In-depth knowledge of GCP principles, clinical research quality standards, global trials, and logistics for multi-country sample handling.

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

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

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

🏝️ Benefits

• Company bonus that is partially dependent on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension scheme.

• Vacation benefits.

• Comprehensive medical, dental, vision, and prescription drug coverage.

• 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, such as an employee assistance program, fitness benefits, and opportunities for employee clubs and activities.

• Employee resource groups and support networks.