Clinical Sample Manager

Duties and Responsibilities

Provide operational oversight of assigned clinical trial service providers, ensuring services are delivered according to study requirements, quality standards, and timelines.

Serve as the primary clinical operations point of contact for clinical trial laboratory vendors.

Oversee clinical trial laboratory vendor activities from study startup through closeout, including laboratory setup, laboratory manual development, kit design, sample collection requirements, test result reporting, and data delivery.

Support operational oversight of other assigned clinical trial service providers, ensuring seamless execution of study requirements and alignment with project timelines, quality standards, and regulatory requirements.

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

Ensure vendor services and deliverables are aligned with protocol requirements, regulatory requirements, and study objectives.

Work cross-functionally with Clinical Development, Quality Assurance, Regulatory Affairs, Finance, and external vendors to ensure activities are conducted in compliance with study protocols, vendor agreements, ICH-GCP, regulatory requirements, and company standards.

Escalate vendor performance issues, operational risks, and quality concerns as appropriate, and drive corrective and preventive actions through resolution.

Supervisory Responsibilities

This position does not have any supervisory responsibilities.

Education/Experience/Skills

Bachelor’s degree in life sciences, laboratory science, or a related field
5+ years of relevant and progressively responsible experience in clinical operations, clinical laboratory operations with 2+ years clinical trial sample management experience within the biotechnology, pharmaceutical, CRO, or laboratory industry required.

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
Understanding of ICH-GCP, regulatory requirements, clinical trial documentation standards, and inspection readiness expectations
Experience with clinical data systems, clinical laboratory data, data transfer specifications, and data reconciliation processes
Demonstrated ability to manage vendors, timelines, budgets, deliverables, risks, and cross-functional communications
Excellent organizational skills and attention to detail and to consistently deliver work product accurately and within deadline
Excellent written and verbal communication skills
Demonstrated proficiency using Microsoft Office applications (Word, Excel, PowerPoint), etc
Experience with Smartsheet and laboratory information management systems preferred

Working Environment and Travel

Generally accepted home office working conditions
Occasional domestic and international travel is expected in this position.

Physical Requirements

While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee will be able to use a computer for extended periods at any given time.
The employee must regularly lift and/or move up to 10 pounds.