Manager, Clinical Laboratory Operations

About this role

Position Description

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. s...