Manager, Clinical Laboratory Operations

Job Category
:
Human Immunology Laboratory

Requisition Number
: MANAG
001397

• Posted :
  February 11, 2026
• Full-Time
• Remote

Showing 1 location

South Africa
IAVI
Ground Floor, Collingwood Building
Black River Park
Cape Town, SA 7925, ZAF

Job Title
:
Manager, Clinical Laboratory Operations (1 year, fixed-term contract)
Location: Cape Town, South Africa OR Remote - South Africa
Reports to
:
Senior Director, Clinical Immunology & Laboratory Operations

Position Summary:

Are you an experienced Laboratory Professional who is eager to make an impact on global health at an innovative and mission driven organization? Learn more here!

IAVI is seeking a dynamic and experienced Manager, Clinical Laboratory Operations to lead lab operations for IAVI-sponsored clinical trials. The Manager coordinates central lab activities, liaises with clinical research sites, clinical teams, and vendors ensuring lab operations are executed effectively. The Manager improves and develops SOPs, prepares the lab for trial operations, and oversees central lab operations. The Manager is knowledgeable and versed in relevant regulations and ensures quality and compliance of lab operations.

Key Responsibilities:

Laboratory operations:

• Coordinate and manage clinical research site (“site”) and central lab related activities, including regular meetings, managing timelines and deliverables, lab budget management, coordinating activities and deliverables with other lab leads for IAVI conducted clinical trials.
• Serve as main point of contact for lab operations for sites, lab vendors and the Clinical Trial Team.
• Support site lab feasibility assessment and conduct site laboratory qualification visits, follow-up and review site laboratory SOPs.
• Contribute to development of lab related information in protocol, ICF, CRF and study operations manuals.
• Develop laboratory operations manual (incl specimen management plan) and update as needed throughout the clinical trial and specimen shipment plan.
• Assist in development of diagnostic algorithms for laboratory endpoints in clinical trials (e.g. TB, HIV).
• Develop protocol specific tools for the management of research samples e.g. sample collection tables, Laboratory Requisition forms, data/sample flow maps.
• Prepare site laboratories for enrollment, including support with procurement of reagents, assay development and testing (if required) and coordinate provision and distribution of central lab supplies and materials.
• Assist in the identification, evaluation, and selection of central laboratories, including review of vendor SOPs, operational strategies, budgets, and support budgeting and contracting activities.
• Develop and implement laboratory quality oversight plan.
• Develop and conduct training for site lab operations during Site Initiation Visit
• Oversee lab related activities at clinical research sites, proactively identifying and resolving issues/risks that arise and implement corrective and preventive measures as required.
• Oversee central laboratory activities, proactively identify and resolve issues that arise and implement corrective and preventive measures.
• Oversee site sample storage e.g. review of temperature reports and management of excursions.
• Review site lab equipment maintenance logs and service records during Lab oversight visits.
• Monitor internal quality control procedures, including monitoring and reporting of contamination rates and cross contamination rates at site labs and /or central laboratories, as applicable.
• Conduct lab quality oversight visits at site labs to ensure compliance with protocol and relevant lab standards.
• Coordinate and oversee internal / external audits of site labs and central labs and coordinate and review CAPAs.
• Ensure lab related essential documents are filed in the TMF throughout the study conduct.
• Oversee central lab / vendor related budget management and review laboratory invoices.
• Coordinate data transfers from laboratories to clinical database, including execution of data transfer agreements.
• Coordinate sample shipments and documentation, including material transfer agreements, export permits, import permits for lab samples and reagents.
• Support data cleaning activities of lab data,…