Technical and Operational Manager

6 months ago

Cape Town, South Africa TASK Full time

**About the Company**:
TASK Laboratory is a core team within TASK, a clinical research institute and social enterprise, committed to state-of-the-art biological laboratory testing and providing these as a service during the development and progression of novelty medicines, vaccines and diagnostics, in particular the TB therapeutic area. TASK performs clinical trials at various sites.

TASK Laboratory consists of biohazard-safety level 2 and 3 (BSL-2/3)laboratories, together with sample reception and media laboratory, and performs testing for drug susceptible and drug resistant TB, using established diagnostic methods and new research platforms.

**Overall Purpose of the Position**:
To provide first class clinical tuberculosis laboratory services by performing technical procedures, laboratory operations and maintenance, data management (including maintenance of key software and Laboratory Information Management System (LIMS) and administrative duties within the scope of activities provided by TASK Laboratory for clinical drug trials and/or related/associated studies.

**Key Performance Areas (KPAs) & Responsibilities include, but not limited to**:
**Overall duties**:

- Managing the activities of Medical Laboratory Technicians, including training and development to ensure they have the skills required to achieve their performance objectives
- Assisting the Head of Laboratory in monitoring productivity and workload of functional areas; identifying peak and slack periods; and assisting in making operational or staffing adjustments
- Assisting the Head of Laboratory with overseeing and monitoring effective utilisation of resources, optimisation of stock levels and reduction of costs. Ensuring that there is adequate stock in the laboratory and no wastage

**Operational duties**:

- Overall responsibility for operational and maintenance management of BSL 2/3 and media laboratory facilities
- Developing and implementing practical plans to perform troubleshooting and critically addressing and resolving laboratory queries
- Managing lab equipment, updating asset register and scheduling equipment service
- Liaising with clients to resolve service-related issues, maintaining a positive image of the organization, and promoting the service of the laboratory
- Reviewing and implementing changes to standard operating procedures to ensure the laboratory is constantly able to provide a high quality, cost effective and safe service
- Assisting with providing reporting data when required, such as annual management reports

**Technical duties**:

- Maintaining technical competence in all processes as per ISO 15189 requirements
- Implementing new programs, testing processes and methods and instrumentation, by investigating alternatives
- Preparing technical proposals and reports (validation and participant specific); developing and performing parallel testing and monitoring progress
- Reviewing and reporting results and interacting with Head of Laboratory and Quality manager on technical matters to maintain effective management of the data required for the efficient functioning and smooth running of the laboratory to meet clinical trial requirements
- Communicating promptly to the Head of Laboratory and Quality Manager any breach in operational matters and quality issues
- Ensuring that all monitoring and data queries are responded to timeously
- Assisting with and contributing towards the maintenance of the quality systems that govern the laboratory and the service components of the laboratory (ensure compliance with GCLP and fulfilment of SANAS accreditation requirements)

**LIMS duties**:

- Setting-up and management of clinical trial parameters to the LIMS (DISA) according to sponsor requirements, including effectively communicating with sponsor and sponsor data team
- Approving LIMS software changes/upgrades and performing QC checks before new project roll out
- Coordinating data transfer agreements with sponsor data teams
- Carrying out any other function relevant to the position as delegated by the Head of Laboratory

**In addition to the above duties, the following duties will be required**:

- Performing specialist technique testing such as MIC, MBLA or PBMC isolation
- Assisting with daily activities of supervisors to ensure that timeous reporting, verifying of results and meeting the expected turnaround times of clinical processes and escalating matters to the Head of Laboratory when the above is not met
- Assisting supervisors with drawing up of the weekly roster for staff rotation for the BSL-3 and BSL-2 laboratory ensuring that all workstations are covered. Ensuring that laboratory productivity is upheld by monitoring workload of functional areas
- Assisting with on-site training of laboratory technologists and technicians in clinical laboratory techniques, processes, and systems. Evaluating them for competency with documented proof

**Ideal Requirements**
- Relevant Scientific qualification: minimum - BSc (Hons)/

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