Project Manager, Brain and Mind Institute at Aga Khan University Hospital

Job Summary

The Biopsychosocial Determinants of Resilient Aging in Kenya (BRAIN-RESILIENCE-KENYA Project), a three-year Wellcome Leap funded project is seeking a Project Manager. This is a specialized role responsible for overseeing and managing research trials from initiation to completion. This position is crucial in ensuring that research projects adhere to protocols, timelines, and regulatory requirements and ensures efficient and effective use of dedicated FTE, while maintaining the highest standards of research integrity.

Responsibilities

• In collaboration with the study Principal Investigators (PIs), develop and refine research trial protocols, SOPs, plans, process flows, manuals, and templates for the study;
• Preparation of ethics and regulatory submissions, study documents (consent form, questionnaires, etc.) and responses/follow-up;
• Develop and implement strategies for participant recruitment, enrollment, and retention;
• Lead the informed consent process and ensure ethical treatment of research participants;
• Ensure compliance with all applicable regulatory requirements and guidelines;
• Ensure ethical conduct in research activities, including adherence to the principles of human research ethics;
• Ensure data accuracy, integrity, and security throughout the trial;
• Identify potential risks and develop risk mitigation plans;
• Maintain clear communication with trial sponsors, investigators, and stakeholders;
• Manage study resources including budget, assets, and human resources; and
• Maintain clear communication with trial sponsors, investigators, and stakeholders.

Requirements

• Master’s in health care related field (or related expertise in clinical research operations). PhD will be an added advantage;
• Human subject protection training including ICH-GCP;
• Minimum 3 years of work experience in research/clinical trials conduct;
• Preferred experience in trial management;
• Current knowledge of best practices in clinical research;
• Knowledge and experience of dealing with all regulatory affairs related to trials;
• Knowledge and experience of going through and participating in audit processes related to research;
• Knowledge in clinical practice, research administration, critical thinking, problem-solving skills, and decision making; and
• Sound knowledge of GCP, FDA and other local and international regulatory guidelines (i.e., Declaration of Helsinki, US code of federal regulations (CFR 45, 21), CIOMS Guidelines, NACOSTI, Pharmacy and Poisons Board).