Manager, Research Administration, Department of Haematology/Onclogy at Aga Khan University Hospital

Job Summary

• The Department of Haemato-Oncology is seeking a Research Administration Manager, to ensure that the studies conducted by the Clinical Research Unit (CRU) meet the standards governed by regulations, laws, and guidelines both locally and internationally for clinical trials. One of the objectives of the organization is to become a center of excellence in conducting clinical trials. This position contributes by ensuring that CRU studies are conducted at high standards in accordance with the applicable local and international regulations, laws, and guidelines. Data Management and Front Office report to the Research Administration Manager.

Responsibilities

• Preparation, review, and submission of all components of ethical and regulatory submissions for new and ongoing clinical trials (new protocols, amendments, safety reports, annual reports, etc.)
• Filling all documents required in an investigator site file.
• Coordinating the preparation and training of SOPs and maintaining the review cycle.
• Assist the investigators and study team in the development and review of study documents (i.e., Protocol, informed consent forms, source documents, site specific addendums, study logs, etc.).
• Maintain up-to-date understanding of the Institutional Ethics Research Committee, Pharmacy and Poisons Board, National Commission of Science, Technology, Innovation, US Department of Health and Human Services, Office of Human Rights Protection, Food and Drug Administration, and European Medicines Agency’s policies by reading articles/publications and attending trainings/seminars.
• Reviewing and monitoring study procedures and documentation to ensure that the trial is conducted according to protocol, Good Clinical Practices, SOPs, and regulatory requirements.
• Responsible for onboarding, ongoing training, and evaluation of all staff in the CRU Data Management section and Office Administrator(s).

Requirements

• Bachelor's degree in related field, Master’s degree is an added advantage.
• At least four (4) years’ experience in research and project management.
• Proficiency in office software, learning management platforms, office management systems and procedures.
• Strong organizational skills with ability to work with minimal supervision.
• Exceptional interpersonal and communication skills both written and verbal communication.
• Demonstrates supervisory skills and ability to work in a multicultural environment.
• Ability to independently prioritize work, critical thinking and problem-solving skills.
• Adaptability to new or changing situations, work under pressure and to meet tight deadlines.
• Ability to maintain confidentiality.

Closing Date: 27/03/2025, 7:59:00 PM