Associate Director, Specimen Management – Lab Start-Up

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🔥 49 minutes ago

🏖️ New Jersey, Pennsylvania – Remote

🏖️ New Jersey – Remote 🔔 Pennsylvania – Remote

💵 $142.4k - $224.1k / year

⏰ Full Time

🟠 Senior

👔 Director

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• Lead laboratory and specimen management activities during study start-up for assigned clinical trials or programs • Review study protocols to assess specimen collection, processing, storage, shipment, and testing requirements • Oversee development and review of laboratory manuals, specimen collection guidelines, requisition forms, and related study documents • Coordinate central laboratory, specialty laboratory, and provider set-up activities to ensure operational readiness prior to site activation • Partner with study teams to align laboratory timelines with broader study start-up milestones • Identify study risks related to specimen handling or lab operations and implement mitigation plans • Oversee end-to-end specimen lifecycle management processes, including: collection requirements, processing workflows, packaging and shipment, chain of custody, sample tracking, reconciliation, and discrepancy management • Ensure specimen operations are executed in accordance with protocol, our expectations, and internal standards • Monitor sample-related metrics, quality issues, and trends to drive timely issue resolution and performance improvement • Provide escalation support for specimen-related operational issues that may impact sites, laboratories, or study timelines • Manage relationships with central laboratories, specialty laboratories, courier/logistics providers, and kit providers • Support provider selection, feasibility assessments, scope review, and operational planning • Oversee provider performance against service level agreements (SLAs), turnaround times, quality expectations, and study deliverables • Facilitate provider governance meetings, performance reviews, and issue escalation/resolution • Ensure external partners are aligned with protocol-specific sample handling requirements and study timelines • Collaborate closely with Clinical Operations, Biomarker Managers, Pharmacokinetics, Data Management, Regional teams, Quality, and other internal stakeholders to support seamless study execution • Act as the subject matter expert for specimen management and lab start-up processes during study planning and execution • Provide recommendations on protocol feasibility and operational design related to specimen collection and laboratory workflows • Communicate study risks, readiness status, and key specimen management updates to internal and external stakeholders • Ensure specimen management and lab start-up activities comply with: Good Clinical Practice (GCP), Applicable GxP requirements, IATA/DOT shipping regulations, internal SOPs and quality standards • Maintain inspection readiness for laboratory and specimen-related processes • Support deviation investigations, root cause analysis, corrective and preventive actions (CAPA), and quality improvement initiatives • Promote consistent documentation practices and operational compliance across studies and teams • Provide day-to-day leadership, coaching, and guidance to specialists, senior specialists, and/or managers supporting specimen management and lab start-up activities • Assist with workload planning, prioritization, and resource coordination across assigned studies or programs • Contribute to staff development, training, onboarding, and performance feedback • Foster a collaborative, accountable, and continuous-improvement-focused team culture • Evaluate existing specimen management and start-up processes to identify opportunities for improvement, standardization, and scalability • Support implementation of new technologies, tools, and workflows to improve specimen visibility, tracking, and operational efficiency • Develop and report key performance indicators (KPIs) related to study start-up readiness, sample quality, reconciliation, and provider performance • Lead or contribute to strategic initiatives to improve site experience, data quality, and operational execution

🎯 Requirements

• Minimum of 5 years in laboratory, biopharmaceutical and/or the supplier industry • Strong interpersonal skills including cross-functional teamwork, and written and oral communication skills • negotiation skills • exceptional analytical skills • multi-cultural skills • high energy level, and a bias toward action • Ability to oversee specimen analysis and effectively summarize and present insights • Solid understanding of clinical development and operations best practices • Microsoft office skilled (e.g., excel and power point) • Biorepository system background

🏖️ Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family) • retirement benefits, including 401(k) • paid holidays, vacation, and compassionate and sick days