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
- Budgeting, financial management, analysis
- Contribute to the strategic direction of international research at Aurum
- Accurate and established Project start-up planners
- Quarterly review of progress to date reported and linked with mitigation strategies to obtain of milestone achievements
- Contribution to the development of protocols, CRFs, database management etc
- Mentor, coach and support of sub-ordinate Programme and Project Managers working within adjunctive host directed therapy and TB vaccine programmatic areas.
- Contribution to bids and grant writing
- Resource management
- Responsible for funder requirements and reporting to funders
- Manage & be accountable for working relationships with all stakeholders (local and international) participating in and/or contributing to programme delivery
- Coordinate communication within a project, liaise between Funders, Sponsors, Aurum management and Clinical Research Sites (local and international)
- Clinical Trials programme and project management
- Provide regulatory expertise
- Site selection, assessment and monitoring of implementation activities (local and international)
- 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)
- 10 years specialist local and international experience local in site start-up, regulatory support, managing multi-country Clinical Research/Trials.
- Managed multiple trials in parallel, sound understanding of the Sponsor role and implementation of Investigator-initiated trials from scratch (local and international).
- Post graduate degree(s) / post-from college or university in Clinical Trials, Health, Science, Medicine or related field
- Willing to work over-time to get the job done in line with reasonable expectations for a senior management position.
- Financially savvy, analytical thinker
- Master’s Degree from college or university in Health, Science, Medicine or related field
- 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: Health Care
Vacancy Type: Full Time
Job Location: Johannesburg, Gauteng, SA
Application Deadline: N/A