Aga Khan University (AKU) is an internationally recognized private, autonomous institution committed to excellence in education, research, and service. Chartered in 1983, the University operates 13 teaching sites across six countries on three continents. As a proud member of the Aga Khan Development Network, AKU is dedicated to empowering societies through innovation, knowledge creation, and impactful social change. The institution offers world-class education in multiple disciplines and has established a reputation for outstanding research and quality healthcare delivery, with seven operational hospitals and over 325 outreach clinics.
With a student body of nearly 2,500 and a workforce of more than 14,000 professionals, AKU continues to influence policy, expand access to healthcare and education, and foster the development of research and leadership across low- and middle-income countries. In line with its vision of transforming lives and communities, AKU is looking to hire a qualified and experienced individual for the position of Manager, Clinical Research Regulatory at its Brain & Mind Institute (BMI) in Nairobi, Kenya.
Position: Manager, Clinical Research Regulatory – Brain & Mind Institute
Job Reference Number: 250001UW
Location: Nairobi, Kenya
Organisation: Aga Khan University Hospital Kenya
Status: Contractual
Type: Standard
Application Deadline: 6 July 2025, 9:59 PM EAT
Overview of the Brain & Mind Institute (BMI)
The Brain & Mind Institute at AKU is dedicated to advancing mental health and neurological science in Africa and Asia. Through multidisciplinary research, innovation, and capacity building, BMI supports initiatives that improve brain health outcomes and address challenges associated with mental health and cognitive disorders across diverse populations.
About the Role
The Manager, Clinical Research Regulatory, will play a critical leadership role in shaping and executing the regulatory strategy and operations at the Brain & Mind Institute. This position is tailored for a proactive, detail-oriented professional with a solid understanding of Good Clinical Practice (GCP) and both local and international regulatory frameworks.
The incumbent will be responsible for ensuring the scientific integrity and ethical conduct of clinical research in line with institutional policies, national laws, and global standards. This includes overseeing regulatory submissions, developing standard operating procedures (SOPs), conducting audits, and supporting ethical participant engagement. The role will also involve training junior regulatory staff, managing site monitors, and serving as a liaison between AKU and external collaborators or sponsors.
Key Responsibilities
1. Regulatory Oversight and Compliance
- Ensure strict adherence to ethical and regulatory guidelines in the execution of all clinical studies.
- Maintain compliance with global and national standards, including those of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – Good Clinical Practice (ICH-GCP), U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), World Health Organization (WHO), and national ethics and regulatory bodies.
- Manage and regularly review Trial Master Files (TMF), Investigator Site Files (ISF), and site essential documents to ensure completeness, certification, and accuracy.
- Initiate corrective actions where documentation is found to be non-compliant or incomplete.
- Oversee and facilitate submission of protocols and associated study documentation to ethics committees and regulatory authorities, including handling amendments and renewal requests.
2. Clinical Regulatory and Site Management
- Design comprehensive, study-specific regulatory plans that include site regulatory strategies tailored to individual research protocols.
- Participate in and supervise site qualification, initiation, monitoring, and close-out visits to ensure regulatory adherence and protocol compliance.
- Review and validate clinical documentation including source data, informed consent forms (ICFs), and case report forms (CRFs), ensuring alignment with the protocol and data integrity.
- Oversee implementation of corrective and preventive actions (CAPAs) in response to monitoring findings or deviations.
3. Quality Assurance and Quality Control (QA/QC)
- Draft and update standard operating procedures (SOPs) covering regulatory activities, documentation practices, audits, and reporting protocols.
- Perform internal audits to detect non-compliance and execute effective CAPAs.
- Monitor data quality in collaboration with the data management team and ensure resolution of data queries in a timely manner.
4. Research Ethics and Participant Welfare
- Guarantee that informed consent procedures are both compliant and culturally sensitive.
- Coordinate with research teams to ensure participant safety, well-being, and full compliance with approved study protocols.
- Address any ethical concerns that arise during the course of the study in a timely and sensitive manner.
5. Capacity Building and Staff Training
- Oversee the onboarding and professional development of regulatory staff at the BMI.
- Create and implement training modules related to GCP, regulatory updates, and newly established SOPs.
- Facilitate regular workshops and performance evaluations to ensure ongoing competency among staff.
- Mentor regulatory personnel and build capacity within clinical research teams.
6. Stakeholder Engagement and Collaboration
- Act as the main point of contact for sponsors, Contract Research Organizations (CROs), investigators, and regulatory partners.
- Organize and coordinate site visits, investigator meetings, and regulatory review discussions.
- Represent AKU in collaborative research networks and ensure alignment of BMI’s regulatory processes with partners’ expectations.
7. Risk Assessment and Escalation Protocols
- Conduct comprehensive risk assessments for ongoing and upcoming research projects, classifying risks based on severity, likelihood, and detectability.
- Work with the Core-Study Coordination Team to devise proactive risk mitigation and response strategies.
- Establish clear escalation protocols to deal with urgent or high-risk regulatory issues effectively.
Qualifications and Requirements
- A master’s degree in a scientific field such as Clinical Research, Public Health, Pharmacy, Neuroscience, Psychology, or an equivalent discipline is preferred. However, candidates with a bachelor’s degree and significant experience will also be considered.
- Strong understanding and demonstrated knowledge of ICH GCP, Declaration of Helsinki, Good Documentation Practices, FDA Code of Federal Regulations (CFR), and other relevant national and international research standards.
- Certification in ICH-GCP and research ethics is required.
- Familiarity with risk-based monitoring strategies and the ability to formulate risk mitigation plans.
- Proven experience working with regulatory authorities including local bodies (e.g., PPB, NAFDAC) and international regulators (e.g., FDA, EMA).
- Skilled in using electronic document management and data capture systems in clinical research settings.
- A minimum of four years of experience in clinical research, including at least three years focused on clinical regulatory management, quality assurance/control, or compliance.
- Previous exposure to research in neuroscience, cognitive disorders, mental health, or global health contexts is highly desirable.
- Ability to train, coach, and mentor regulatory or clinical operations staff.
Personal Attributes
- Strong interpersonal and communication skills; able to work with internal teams and external partners with professionalism and cultural sensitivity.
- Proven ability to manage complex projects independently, multitask across various priorities, and meet deadlines consistently.
- Detail-oriented and analytical, with a commitment to maintaining the highest standards of data accuracy and ethical conduct.
- Willingness to work in dynamic, evolving environments and adapt to changing organizational needs.
- Excellent presentation and writing skills, capable of delivering technical content to both expert and lay audiences.
Application Process
All applications for this position must be submitted by 6 July 2025 at 9:59 PM EAT. This is a unique opportunity to join a dynamic and mission-driven team committed to improving brain health outcomes and advancing clinical research in Africa and beyond. The successful candidate will not only play a pivotal role in safeguarding the integrity of BMI’s research portfolio but also contribute to building a foundation for ethical, high-quality studies across the region.
Interested and qualified candidates are encouraged to apply promptly before the deadline. The Aga Khan University is an equal opportunity employer and welcomes applications from all qualified individuals regardless of gender, race, religion, or background.
For email-based applications, please refer to the university’s official website or careers portal for submission guidelines.
If applications are being submitted online, please use the link below:
