Laboratory Manager

**Job Title : Laboratory Manager
**Annual Salary** : Occupation Specific Dispensation (OSD)***

**Location **:Ndevana Community Research Site

**Department** : Research Unit

**Reporting to **:Medical Officer - Clinical Trials***

**Purpose of the position**:
The main purpose of this position is to manage all laboratory activities at the Ndevana
Community Research Site laboratory, including oversight of on-site diagnostics, performing
laboratory rapid tests in line with donor and laboratory standards, safe handling of specimens,
quality assurance (QA) / quality control (QC) processes (IQC and EQA), reporting on Good
Clinical Laboratory Practice (GCLP) and Good Clinical Practice (GCP) and accountability to all
research sponsors.

**Main responsibilities**:
Plan, organize, direct, control and coordinate the operations of the FPD Clinical Research

Laboratory.

procedures, GCLP principles and laboratory quality improvement plan to ensure compliance.
- Plan the activities of the laboratory team and delegate tasks to ensure performance

objectives are achieved.
***
- Responsible for equipment calibration and maintenance to ensure accurate and reliable

results.***
- Implement safe working conditions and procedures to ensure a safe working environment

and compliance with all legislation.***
- Ensure that the team is familiar with and adheres to safety rules and regulations.***

the shipment of material into and out of South Africa as required by the various research

studies.***
- Ensuring the preservation of the integrity of all investigational material.***
- Manage the implementation of study start-up and close out activities.***

and SOPs to ensure corrective actions are taken as required.***
- Coordinate, develop or revise laboratory related SOPs as required in order to ensure the

laboratory is constantly able to provide high quality, cost effective and correct results.***
- Evaluate and QC the results from trials thereby ensuring accuracy and identifying trend in

order to address skills gaps.
***
- Perform training to bridge the skills gaps thereby ensuring competence.**
- Ensure that the laboratory is compliant with GCLP.***
- Timeously perform method validation, the establishment of new assays by overseeing the

process in real time.
***
- Review and approve laboratory orders in accordance with established procedures.***
- Inspect, verify and check delivered goods and stock as per orders.***
- Maintain stock inventory logs for all studies.
- Oversee the management and storage of biohazardous waste and toxic materials.***
- Oversee all aspects of specimen processing including performing of point of care rapid tests

and reporting of results.***
- Oversee the transport and shipping of clinical specimens.***
- Attend to all laboratory related staffing requirements and administration.***

**Essential Qualification and Registration**:

- BSc or National Diploma in Medical Technology (Preferably in Microbiology, Virology).
- HPCSA registration as Medical Laboratory Technologist.

**Advantageous qualifications**:

- Post graduate qualification specifically inclusive of research and data management content.
- Certification in Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP).
- Dangerous Goods / IATA training certificate.

**Job-related experience**:

- Minimum of 5 years’ experience in the laboratory environment.
- Minimum of 1 year experience in a research environment.
- Previous management experience (advantageous).

**Additional requirements**:

- Sound knowledge of laboratory information systems.
- Computer literacy including Microsoft Office at an Intermediate level.
- Proficiency in reading, speaking, and writing English.
- Valid code 08 driver’s license and own vehicle.
- Willingness to travel and to use own vehicle.
- Applicants are advised that the Foundation for Professional Development has elected to _
- implement a mandatory COVID-19 vaccination policy to protect the health and safety of its _
- employees, faculty, students, clients, and others who work with, train, or receive other services _
- from FPD.**Please note**:
Only applicants shortlisted for interviews will be contacted. If you have not been contacted
was unsuccessful.