Manager, Clinical Laboratory Operations

Job Category: Human Immunology Laboratory

Requisition Number: MANAG001397

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

Locations 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, in consultation with Data Management.
• Coordinate sample destruction / storage and documentation at the end of the study.
• Perform any other duties as assigned by the Line Manager.

Departmental and knowledge development activities:

• Remain up to date on knowledge of GCP, GCLP and other relevant regulations.
• Remain abreast of scientific knowledge, EQA programs and TB, HIV and Emerging Infectious Disease (EID) diagnostic technologies, trends, and activities.
• Participate in training activities for new staff, as needed.

Education and Work Experience:

• Bachelor's in life sciences, public health, or related field is required; An advanced degree is preferred;
• A minimum of 5 years' work experience in a relevant role, academic, nonprofit organization, and/or research environment is required.
• Knowledge and experience in research endpoint assays is preferred (e.g. PBMCs, ELISpots, etc.)
• Scientific & Technical training; preferably laboratory qualification in Clinical Pathology but professional qualifications from state registered bodies and /or experience working in accredited laboratories also considered.

Qualifications and Skills:

• Ability to conduct presentations of technical information is required.
• High level of interpersonal skills and the ability to work effectively in a cooperative and collaborative manner with all levels, across functional teams both internally and externally is required.
• Ability to work on problems of moderate complexity and diverse scope using good judgment within defined procedures and policies to determine appropriate action is required.
• Excellent project planning and implementation skills in a cross-disciplinary and multi-cultural team are required.
• Excellent knowledge of ICH GCP, FDA CFR guidelines, GCLP, and relevant country specific regulations related to laboratory operations are required.
• Excellent verbal and written communication skills are required.
• Flexibility to change priorities and be comfortable with changing deadlines to meet organizational needs is required.
• Excellent computer skills and proficiency in Microsoft Word and Excel is required.
• Ability to travel up to 50% of the time is required.
• Extensive hands on experience in TB diagnostic laboratories is preferred.
• Knowledge of TB and HIV diagnostic testing algorithms is required
• High level of independence in performing responsibilities is highly desirable.
• Strong Clinical Trials background is highly desirable.

Organizational Overview:

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., IAVI is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in country research capacity and supports the training and education of the next generation of scientists. The global impact of our science includes fundamental contributions to understanding the biology of HIV infection, which IAVI and others are applying toward advancing vaccine science and immunology. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases. Through the Product Development Center, we support external researchers with technical and scientific expertise to accelerate the development of their own products.

IAVI CORE VALUES:

• Commitment: We deliver on our mission, proactively transforming promises into tangible results
• Stewardship: We steward IAVI's resources responsibly to ensure IAVI's long term success and global health impact
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