Clinical Sample Manager

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

📋 Description

• Provide operational supervision of assigned clinical trial service providers, ensuring that services are delivered in accordance with study requirements, quality standards, and timelines.

• Act as the primary clinical operations contact for clinical trial laboratory vendors.

• Manage clinical trial laboratory vendor activities from study initiation through completion, including laboratory setup, development of laboratory manuals, kit design, requirements for sample collection, test result reporting, and data delivery.

• Serve as the main point of contact for laboratory-related clinical trial operations for both internal and external study teams, overseeing crucial operational deliverables such as laboratory manuals, data transfer specifications, sample management plans, vendor operational plans, and study-specific training materials.

• Review and contribute operational insights into clinical protocols, informed consent forms, and other study-related documents.

• Supervise sample management tasks, including site supply management, kit ordering, tracking sample shipments, laboratory result reporting, and resolving issues.

• Collaborate with internal stakeholders and external vendors to ensure proper handling of clinical laboratory samples, including specialty samples such as pharmacokinetic (PK), pharmacodynamic (PD), biomarker, immunogenicity, genetic, and safety laboratory samples, as necessary.

• Work closely with Clinical Operations study teams to facilitate the successful execution of clinical trial activities.

• Partner with Clinical Operations, CROs, investigative sites, laboratory vendors, and other stakeholders to ensure effective planning and execution of study-related operational tasks.

• Monitor clinical site performance and support site-facing communications regarding laboratory procedures, sample collection requirements, shipping instructions, and process changes.

• Ensure the quality, completeness, and timeliness of clinical trial laboratory data and data transfers from vendors to internal systems, data management platforms, and electronic data capture (EDC) systems.

• Assist with laboratory and vendor data reconciliation activities, including sample reconciliation, follow-up on missing data, query resolution, and review of out-of-range or clinically significant laboratory results.

• Confirm that vendor services and deliverables align with protocol requirements, regulatory standards, and study objectives.

• Collaborate across functions with Clinical Development, Quality Assurance, Regulatory Affairs, Finance, and external vendors to ensure all activities comply with study protocols, vendor agreements, ICH-GCP, regulatory requirements, and company standards.

• Work with Clinical Development, Clinical Operations, and Finance to assist with contracting activities, budget management, change order review, and invoice reconciliation.

• Escalate vendor performance issues, operational risks, and quality concerns as necessary, driving corrective and preventive actions to resolution.

• Perform other duties and responsibilities as assigned.

⛳️ Requirements

• Bachelor’s degree in life sciences, laboratory science, or a related field.

• 5+ years of relevant and progressively responsible experience in clinical operations, specifically in clinical laboratory operations, with at least 2+ years of clinical trial sample management experience within the biotechnology, pharmaceutical, CRO, or laboratory industry.

• Experience managing central laboratory, clinical laboratory, or specialty laboratory operations/data/vendors in support of clinical trials.

• Strong understanding of clinical research, clinical trial operations, laboratory sample workflows, and site/vendor logistics.

• Knowledge of ICH-GCP, regulatory requirements, clinical trial documentation standards, and expectations for inspection readiness.

• Experience with clinical data systems, clinical laboratory data, data transfer specifications, and data reconciliation processes.

• Proven ability to manage vendors, timelines, budgets, deliverables, risks, and cross-functional communications effectively.

• Ability to multitask, manage several studies, vendors, and priorities simultaneously, and thrive in a fast-paced team environment.

• Excellent organizational skills and attention to detail, consistently delivering accurate work products within deadlines.

• Strong written and verbal communication skills.

• Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint), among others.

• Preferred experience with Smartsheet and laboratory information management systems.

🏝️ Benefits

• Generally accepted home office working conditions.

• Occasional domestic and international travel is anticipated in this role.