Senior Manager, Clinical Laboratory Operations

Zenas BioPharma•Waltham, MA

1d•$134,500 - $168,228•Hybrid

About The Position

The Senior Manager, Clinical Laboratory Operations will be responsible for leading the operational execution of laboratory sample collection, tracking, testing, reconciliation, data transfer, and final sample disposition across Zenas’ clinical development programs. This role will partner closely with Translational Sciences, Clinical Development, Clinical Operations, Data Management, Quality Assurance, Procurement, Legal, Finance, CROs, central laboratories, and specialty biomarker vendors to ensure all laboratory activities are delivered with quality, compliance, efficiency, and clear communication. The successful candidate will bring strong clinical sample management expertise, vendor oversight experience, and operational leadership to support high-quality laboratory data generation that informs clinical development strategy.

Requirements

Bachelor’s degree in life sciences, clinical research, laboratory sciences, or a related discipline required; advanced degree preferred.
6+ years of relevant experience in clinical sample management.
Strong working knowledge of clinical sample collection, processing, shipping, inventory tracking, testing workflows, data transfers, sample reconciliation, and long-term sample storage requirements.
Demonstrated experience managing external vendors, including CROs, central laboratories, specialty biomarker laboratories, sample storage vendors, and other clinical trial service providers.
Experience supporting global clinical trials and working cross-functionally
Familiarity with GCP, ICH guidelines, informed consent requirements, sample chain of custody, data privacy considerations, and clinical trial inspection readiness expectations.
Proven ability to manage multiple studies, vendors, priorities, budgets, and timelines in a fast-paced, matrixed environment with strong attention to detail and quality.
Excellent communication, collaboration, problem-solving, and organizational skills, with the ability to influence internal and external stakeholders and drive issues to resolution.
Comfort operating in a growing, entrepreneurial organization and contributing to process development, continuous improvement, and scalable biomarker operations infrastructure.

Responsibilities

Plan and manage biomarker, bioanalytical and central lab sample logistics across clinical trials, including sample kits and supplies, collection, processing, shipment, testing, reconciliation, storage, inventory tracking, chain of custody, use tracking, and final disposition.
Serve as the laboratory operations lead on assigned study teams, providing input into clinical protocols, informed consent forms, laboratory manuals, sample collection schedules, sample management plans, collection guidance, inventory tracking processes, data delivery timelines, and related study documents.
Oversee and manage external laboratories, CROs, central labs, specialty testing vendors, sample storage vendors, and other clinical trial service providers, including identification, qualification, onboarding, performance management, issue resolution, review of scopes of work, budgets, contracts, laboratory capabilities, operational risks, and adherence to contractual scope, budget, and timelines.
Coordinate data transfer specifications, sample reconciliation outputs, testing status updates, final deliverables, and delivery of quality data in collaboration with Translational Sciences, Data Management, Clinical Operations, and vendors.
Support inspection readiness, quality activities, process improvements, and gap assessments by ensuring lab-related documentation is complete, current, and filed appropriately, while proactively identifying, escalating, and resolving operational risks, bottlenecks, and quality issues related to lab sample handling, testing, and reporting.
Drive continuous improvement of lab sample operations processes, templates, vendor oversight practices, sample management systems, and scalable biomarker operations infrastructure across the clinical portfolio.