Laboratory Manager - Thika at Kenya Medical Research - KEMRI

Key Responsibilities:

• Support the Laboratory Director and Principal Investigators in the overall leadership, planning, coordination and day-to-day operation of the Clinical Research Centre Laboratory.
• Lead the implementation, maintenance and continuous improvement of the laboratory Quality Management System (QMS), in line with ISO 15189, GCLP, approved study protocols, institutional policies and applicable regulatory requirements.
• Ensure accurate, reliable and timely laboratory results by overseeing pre-examination, examination and post-examination processes, including specimen collection/phlebotomy, testing and technical supervision as required.
• Able to drive risk assessment processes across pre-examination, examination, and post-examination processes, and implementing corrective action and preventive action (CAPA) plans.
• Serve as the primary laboratory point of contact for clinical teams, investigators and collaborators on laboratory operations, results, interpretation within scope, specimen flow and logistics.
• Establish and maintain effective laboratory workflows, roles, escalation pathways and communication structures to support safe, efficient and accountable service delivery.
• Conducting protocol for specific laboratory tests & procedures and writing and implementing laboratory analytical plans for newly implemented research studies.
• Responsible for providing Laboratory Audit oversight by directing internal and external quality audits, managing non-conformity investigations, root-cause analyses, and ensuring timely audit closures.
• Be able to establish, track, and report Quality Indicators (QIs) and key metrics (e.g., Test Turnaround Time (TAT), critical result reporting compliance, customer feedback, etc).
• Coordinate shipment of biological specimens, including required approvals and documentation, compliant packaging, courier liaison, shipment tracking and confirmation of receipt with collaborating laboratories.
• Liaise closely with clinic teams and strengthen the laboratory-clinic interface to support specimen quality, timely communication of results, participant safety and adherence to study protocols.
• Coordinate laboratory regulatory and compliance activities, inspections, mandatory training and documentation, and maintain ongoing inspection and accreditation readiness.
• Oversee reagents and consumables supply-chain control, including forecasting, procurement, inventory management, lot-to-lot verification, expiry monitoring, critical storage conditions and mitigation of stock-outs.
• Manage participation in External Quality Assessment (EQA) / Proficiency Testing (PT) programs and ensure proper evaluation and corrective action for out-of-range outcomes
• Responsible for all the laboratory equipment, instruments, analytical methods, and Laboratory Information Management Systems (LIMS) and to ensure that the equipment undergo proper calibration, maintenance, validation, and verification before clinical use.
• Maintaining laboratory records, data management and good documentation practices.
• Ensures adherence to study protocols and enforce biosafety guidelines, chemical safety protocols, waste disposal regulations, and occupational health standards incident-reporting and emergency-response requirements.
• Conduct staff supervision and competency by recruiting, onboarding, evaluating and mentoring laboratory staff. This includes documenting annual staff performance and appraisals, orientation and training of new employees.
• Manage staffing levels, schedules, duty rotas to ensure uncompromised daily service delivery, as well as promoting continuous education, training programs, and safety updates for technical and administrative personnel.
• Coordinating collaborations with other laboratories and technical interfaces with other laboratories, research teams and partner institutions.
• Serve as liaison to internal and external investigators and collaborators and referral laboratories, ensuring clear communication of laboratory requirements, timelines and deliverables.
• Oversee service level agreements (SLAs), equipment maintenance contracts, and third-party referral laboratory arrangements.
• Ensures on-going integrity of laboratory samples by overseeing all handling and repository projects while assuring accurate documentation and adherence to protocols and to timelines.
• Advise the Laboratory Director and Principal Investigator on technical, quality, staffing, biosafety and resource issues, and undertake other laboratory management duties as assigned.

Vacancy Requirements:

• Possess a degree in Medical Laboratory Sciences or related discipline.    Mandatory
• Master's degree in a relevant science or laboratory-related field.    Mandatory
• At least seven (7) years’ experience in a busy clinical research laboratory.    Mandatory
• At least five (5) years’ experience in a management position.    Mandatory
• Experience working in an ISO 15189 accredited laboratory.    Mandatory
• Experience in carrying out laboratory testing for research and/or clinical trials.    Mandatory
• Experience in usage of Laboratory information Management systems (LIMS).    Mandatory
• Must possess a scientific imagination commensurate with the independent execution of research projects.    Mandatory
•  Training in Good Clinical Laboratory Practice (GCLP); Good Clinical Practice (GCP) and Human Subjects Protection training are an added advantage.    Added Advantage
•  Experience in laboratory audit processes.    Mandatory
•  Strong technical troubleshooting, analytical thinking, data interpretation and problem-solving skills.    Skills & Competencies
• Demonstrated ability to supervise, mentor and develop laboratory staff, interns and students, and to manage competing operational priorities.    Skills & Competencies
• Strong leadership, communication, interpersonal, organizational and stakeholder-management skills.    Skills & Competencies
• Proficiency in standard office applications and the ability to analyse and trend laboratory quality-control and operational performance data.    Skills & Competencies