Laboratory Manager

The Laboratory Manager will provide leadership, planning, coordination, and daily operational management for the Clinical Research Centre Laboratory. This role involves implementing and maintaining a robust Quality Management System (QMS) in adherence to ISO 15189, GCLP, approved study protocols, institutional policies, and regulatory requirements. Key responsibilities include ensuring accurate, reliable, and timely laboratory results by overseeing all pre-examination, examination, and post-examination processes, including specimen handling, testing, and technical supervision. The manager will also drive risk assessment, manage audit processes, ensure regulatory compliance, oversee supply chain management for reagents and consumables, manage laboratory equipment, and supervise and mentor laboratory staff.

1. Support the Laboratory Director and Principal Investigators in the overall leadership, planning, coordination, and day-to-day operation of the Clinical Research Centre Laboratory.
2. 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.
3. 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.
4. Drive risk assessment processes across pre-examination, examination, and post-examination processes, and implement corrective action and preventive action (CAPA) plans.
5. 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.
6. Establish and maintain effective laboratory workflows, roles, escalation pathways, and communication structures to support safe, efficient, and accountable service delivery.
7. Conduct protocol for specific laboratory tests and procedures and write and implement laboratory analytical plans for newly implemented research studies.
8. Be 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.
9. Establish, track, and report Quality Indicators (QIs) and key metrics (e.g., Test Turnaround Time (TAT), critical result reporting compliance, customer feedback, etc).
10. Coordinate shipment of biological specimens, including required approvals and documentation, compliant packaging, courier liaison, shipment tracking, and confirmation of receipt with collaborating laboratories.
11. 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.
12. Coordinate laboratory regulatory and compliance activities, inspections, mandatory training and documentation, and maintain ongoing inspection and accreditation readiness.
13. 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.
14. Manage participation in External Quality Assessment (EQA) / Proficiency Testing (PT) programs and ensure proper evaluation and corrective action for out-of-range outcomes.
15. Be responsible for all 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.
16. Maintain laboratory records, data management, and good documentation practices.
17. Ensure adherence to study protocols and enforce biosafety guidelines, chemical safety protocols, waste disposal regulations, and occupational health standards incident-reporting and emergency-response requirements.
18. 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.
19. 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.
20. Coordinate collaborations with other laboratories and technical interfaces with other laboratories, research teams, and partner institutions.
21. Serve as liaison to internal and external investigators and collaborators and referral laboratories, ensuring clear communication of laboratory requirements, timelines, and deliverables.
22. Oversee service level agreements (SLAs), equipment maintenance contracts, and third-party referral laboratory arrangements.
23. Ensure ongoing integrity of laboratory samples by overseeing all handling and repository projects while assuring accurate documentation and adherence to protocols and to timelines.
24. Advise the Laboratory Director and Principal Investigator on technical, quality, staffing, biosafety, and resource issues, and undertake other laboratory management duties as assigned.

1. Possess a degree in Medical Laboratory Sciences or a related discipline.
2. Hold a Master’s degree in a relevant science or laboratory-related field.
3. Have at least seven (7) years of experience in a busy clinical research laboratory.
4. Possess at least five (5) years of experience in a management position.
5. Experience working in an ISO 15189 accredited laboratory.
6. Experience in carrying out laboratory testing for research and/or clinical trials.
7. Experience in the usage of Laboratory Information Management Systems (LIMS).
8. Must possess scientific imagination commensurate with the independent execution of research projects.
9. Experience in laboratory audit processes.
10. Strong technical troubleshooting, analytical thinking, data interpretation, and problem-solving skills.
11. Demonstrated ability to supervise, mentor, and develop laboratory staff, interns, and students, and to manage competing operational priorities.
12. Strong leadership, communication, interpersonal, organizational, and stakeholder-management skills.
13. Proficiency in standard office applications and the ability to analyze and trend laboratory quality-control and operational performance data.
14. Training in Good Clinical Laboratory Practice (GCLP), Good Clinical Practice (GCP), and Human Subjects Protection training are an added advantage.