Website The Aurum Institute
The TB Clinical Director will be responsible for the effective management of two or more large international projects, and will oversee implementation at partner / collaborator sites, locally and internationally. The role requires trial Sponsor implementation and management experience in managing international teams and providing the necessary start-up, regulatory and Sponsor support relevant for the specific country(ies). The TB Clinical Director would need to provide technical oversight and accountability for the project and would need to work with other related role players in achieving, maintaining, improving, tracking and reporting of expenditure against budget, timelines, trial performance metrics, study start-up activities and quality indicators
- Apply knowledge and understanding of TB, HIV/Aids and or Covid-19 within the projects
- Resource management (local Aurum site staff)
- Contractual negotiation: drafting scope of work, payment / disbursement terms and aligning to milestone and budget schedule(s).
- New projects / concepts (pre-project) generated implemented (investigator led or sponsor initiated), which differ in objectives (including secondary and other) to current projects. Examples would include sub-studies and or additional analyses on existing data in addition to potentially new projects or cohorts etc
- Contract negation – mitigate risk, establish and review scope of work, develop payment terms in line with milestones and budget (local and international stakeholders)
- Data Management support (initial design of eCRFs, co-ordinate data management review of endpoint data fields)
- Analysis of risk and implementation of trial project risk mitigation strategies
- Conitniously report on project outputs to relevant stakeholders
- Apply knowledge of ICH and SA GCP and ensure compliance
- Contribute towards manuscript, abstract and or poster development for conferences / symposiums.
- Review current Programme updates, challenges, resources, progress and critical path tasks
- Ensure regulatory compliance and quality assurance for projects
- Excellent personal computer skills
- Protocol development
- Experience in analyzing data and summarizing vast amounts of data into graphs
- At least 5 years’ experience Programme Management (or in managing multiple trials at any given time)
- Tracking of expenditure (budgeted versus actual and actual versus project progress progress) and annual funder reporting.
- Experience in implementing trials at international site(s) in one or more of the following non-African countries: Romania, Moldova, Georgia, Germany ; and in one or more of the following African countries: Mozambique, South Africa and others as may be applicable.
- Moderate/Excessive overnight travel (up to 33%) by land or air if required (local and international)
- Advanced MS Work, Excel, Power Point & Project
- SA Citizen or valid work permit to work in South Africa
- Project Management qualification
- Portuguese, French and/or other major African languages preferred
Company: The Aurum Institute
Job Category: Retail
Vacancy Type: Full Time
Job Location: Johannesburg, Gauteng, SA
Application Deadline: N/A