The application closing date:
29 Sept 2026
Description:
The Clinical Trials Unit (CTU) Manager will be responsible for operational oversight, planning, implementation and conduct of assigned clinical trials and in compliance with applicable clinical and regulatory standards to ensure successful clinical trial implementation and execution.
The CTU Manager will provide leadership and manage a support team in executing the clinical trials. He/she is a key member of the clinical operations team dedicated to achieving and exceeding business objectives through efficient execution, high quality, and timely deliverables of all associated aspects of the trial, in compliance with investigational device regulatory requirements and Good Clinical Practice guidelines.
The CTU Manager will work closely with cross-functional teams, including clinical research associates, investigators, and vendors, to ensure the successful execution of clinical trials from initiation to completion. Their exceptional organizational skills, attention to detail, and strong leadership abilities will contribute to the advancement of AHRI clinical development programs.
Overview of duties:
- Manage and oversee the planning, implementation, and execution of clinical trials and studies, adhering to applicable regulations and guidelines.
- Develop and maintain detailed project plans, timelines, and budgets to ensure successful trial execution.
- Collaborate with cross-functional teams, including, data management, laboratory, and regulatory affairs, to ensure alignment and effective communication throughout the trial process.
- Manage relationships with external vendors and CROs, providing oversight and ensuring compliance with study protocols, regulatory requirements, and quality standards.
- Monitor the progress of clinical trials, identify potential issues or risks, and implement mitigation strategies to ensure study timelines and objectives are achieved.
- Prepare and review study-related documents, including protocols, informed consent forms, case report forms, and study reports.
- Ensure compliance with regulatory and ethical standards, including GCP guidelines and applicable local and international regulations.
- Coordinate and participate in site initiation visits, monitoring visits, and study close-out activities.
- Provide leadership and guidance to the clinical operations team, fostering a culture of collaboration, accountability, and continuous improvement.
- Participate in review of site contracts and budget negotiations.
- Review and update standard operating procedures and processes, ensuring efficiency and cost-effectiveness.
- Review of strategies, projects targets and recruitment plan in order to improve or alter strategy to achieve projects objectives.
- Liaise with all stakeholders within the organisation at all levels of the business in order to meet programme goals.
- Community engagement to better understand the impact of on the community, and the perceptions of the community on our projects and improve the relations between the two entities.
- Identify and mitigate risks in all areas and implement contingency measures where possible.
- Ensure timely advertisement of vacant posts, conduct interviews and placement of suitable candidates with the support of HR and the relevant manager/s.
- Regularly assess performance of subordinates; appropriate incentive bonuses and setting KPAs for staff.
- Hold regular meetings with the coordinators, and with all staff members (when necessary) to provide leadership role in any matter.
- Coordinate activities of the various projects so as to ensure adequate staff in each project and rotation of staff if necessary - bearing in mind peak and low visit times; start-ups and projects closures.
- Ensure that staff receive ongoing training and support when required.
Minimum Qualifications:
- A life science or healthcare field degree or equivalent; a Masters’ degree preferred.
Minimum Experience:
- Five years of experience in a clinical research management position.
- Previous experience in conducting clinical trials desired (minimum of 2 years coordinating a clinical trial.
- Robust knowledge of GxP and management.
- Familiarity with HIV/AIDS and/or TB and/or COVID-19 and Africa medical settings are desired.
- End-user computer efficiency, with proficiency in Microsoft Office products.
Skills Required:
- Good verbal and written communication skills in English.
- Accuracy and precision.
- Good knowledge of GCP and HSP.
- Knowledge of Electronic data systems.
- Previous Project management.
- Ability to coach, guide and mentor the study staff.
- Availability to travel locally and internationally when required.
Worker Type:
Employee
AHRI is a values-driven organisation. As an employer we are committed to staff engagement and development. Our culture is one of high performance and partnership.
Our values
The successful candidate will be expected to live by AHRI’s values, including collaboration, ubuntu, leadership, innovation, transformation, and excellence.
Employment equity
AHRI is fully compliant with South African labour law and is committed to employment equity. This position is primarily open to South African or other African applicants, with a valid work permit desirable. AHRI reserves the right in special circumstances to accept late applications or to extend the above date to facilitate further searches. Furthermore, AHRI reserves the right not to make an appointment.
Please note that only shortlisted candidates will be contacted, kindly consider your application as unsuccessful if you do not hear from us within 14 days of the application closing date.
