The Clinical Sample Manager is responsible for the planning, coordination, oversight, and execution of operational activities that support the successful conduct of global clinical trials, with primary responsibility for the management of central laboratory and other assigned clinical trial vendors and service providers. This role ensures the timely and compliant delivery of laboratory services, study materials, sample management processes, vendor deliverables and operational execution throughout the clinical trial. The incumbent will support operational oversight of other assigned clinical trial service providers and study activities, ensuring seamless execution of study requirements and alignment with project timelines, quality standards, and regulatory requirements.
Duties and Responsibilities (Responsibilities include but are not limited to):- 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.
- Serve as the primary point of contact for laboratory-related clinical trial operations for internal and external study teams, overseeing key operational deliverables, including laboratory manuals, data transfer specifications, sample management plans, vendor operational plans, and study-specific training materials.
- Review and provide operational input into clinical protocols, informed consent forms, and other study-related documents.
- Oversee sample management activities, including site supply management, kit ordering, sample shipment tracking, laboratory result reporting, and issue resolution.
- Coordinate 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 applicable.
- Partner closely with Clinical Operations study teams to support the successful execution of clinical trial activities.
- Collaborate with Clinical Operations, CROs, investigative sites, laboratory vendors, and other stakeholders to ensure effective planning and execution of study-related operational activities.
- Monitor clinical site performance and support site-facing communications related to laboratory procedures, sample collection requirements, shipping instructions, and process changes.
- Oversee 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.
- 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.
- Partner with Clinical Development, Clinical Operations, and Finance to support contracting activities, budget management, change order review, and invoice reconciliation.
- Escalate vendor performance issues, operational risks, and quality concerns as appropriate, and drive corrective and preventive actions through resolution.
- Other duties and responsibilities as assigned.
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.
- Ability to multitask, manage multiple studies, vendors, and priorities simultaneously and work in a fast-paced team environment.
- 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.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets