Main purpose of the job
To manage and coordinate the activities of the IAVI laboratory programme according to good clinical laboratory practice, standards and according to the sponsor requirements (study protocols).

Location
Clinical Laboratory Services, Braamfontein. Travelling to a number of African countries will be required.

Key performance areas
• Prepare and submit timely reports on laboratory monitoring visits to the IAVI Laboratory QA Manager.
• Review project protocols and gain understanding of the scope of the contract and any services agreement in place for IAVI.
• Prepare project plans, project status and other administrative reports and submit to IAVI as required by the contract with them, and other internal stakeholders.
• Manage and monitor the financial objectives of the project, providing feedback to management and the sponsor on utilization of funds, areas of concern regarding expenditure, mid-year modifications inclusive of transfer of funds across budgets.
• Transform research protocol into workable analytical/ study plans to enable the laboratory staff to conduct necessary tests and procedures.
• Coordinate study activities i.e. ensure no outstanding results, samples stored, QC shipping of samples, stock control.
• Schedule regular project meetings with team members to discuss operational issues i.e. progress, deliverables, etc.
• Monitor and report on project progress and resources to ensure compliance and adherence to the project plan.
• Prepare comprehensive meeting minutes, monthly and quarterly summaries and site assessment reporting.
• Report to and communicate with all project stakeholders and sponsors.

Specific project details
• Overall management and supervision of the project in line with sponsor requirements and the scope of work (SOW).
• To assure adherence and compliance to GCP and GCLP for all HIL-CRU QA related activities at the African CRCs.
• To conduct regular / scheduled laboratory monitoring visits to ensure GCP and GCLP adherence to IAVI sponsored Clinical Trials / Epidemiological studies approved study documents.
• Perform on-site troubleshooting and technical training including study protocol specific laboratory trainings.
• Assist in the development of HIL-CRU Laboratory QA monitoring and monitoring tools.
• Provide input and support in the development of core QA processes for the HIL –CRU field CRCs including: Procedures, Training, Exceptions-Investigations and Corrective and Preventative Actions.
• Be part of the QA team for review and approval cycle as it pertains to the quality aspect for SOPs, SLMs, Validation documents and other controlled documents.
• Conduct African CRU laboratory related audits with the advice and input from the IAVI CRU Laboratory QA manager Africa.

Required minimum education and training
National Diploma in Biomedical Technology (3 years) or BSc Medical Science.

Required minimum work experience
Minimum 4 – 5 years bench experience in an Accredited Laboratory.
Proven professional experience in a clinical or research laboratory in the following disciplines will be an advantage:
• Clinical Chemistry
• Haematology
• Microbiology
• Serology
• Immunology

Professional body registration
Registration with HPCSA as Medical Technologist/Medical Scientist.

Additional education, work experience and personal abilities
• Certification in Laboratory Monitoring, Quality Assurance or a related discipline.
• Ability to adjust working hours to achieve goals and deadlines.
• Ability and willingness to travel both within African developing countries, to attend conferences and to train and interact with scientists and African Clinical Research Centres laboratory staff at short notice where applicable.
• Clinical trials experience in Africa.
• Good Clinical Laboratory Practice (GCLP) certification and SANAS standards.
• Proficiency in method/instrument validations will be required.
• Operate in a pressurized where responsibilities associated with the role are broad and demands achievement of a wide ranging number of deliverables simultaneously.
• Working knowledge of Microsoft Office.
• Must be meticulous and have good attention to detail with above average written and verbal communication skills.
• Understanding business principles and areas of business including ability to develop budgets and costing on projects.
• Achievement driven and self-confident personality.
• Ability to work independently will be advantageous.
• Client interaction and negotiation required.
• Effective oral and written communication / presentation skills in GCP/GCLP regulated environment are required.
• Ability to solve problems not covered by existing guidelines and adapt working practices accordingly is desirable.
• Project Management and Resource Planning Skills will be beneficial.
• Experience with Electronic Quality Management Systems is desirable.
• Experience in Auditing is desirable.

The Wits Health Consortium will only respond to shortlisted candidates. Candidates who have not been contacted within two weeks of the closing date can consider their applications unsuccessful. In accordance with our Employment Equity goals and plan, preference will be given to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.