Aga Khan University Hospitals in Karachi, Pakistan and Nairobi, Kenya are private, not-for-profit institutions providing high quality health care. The Main Hospitals serve as the principal sites for clinical training for the University's Medical Colleges and Schools of Nursing and Midwifery in Pakistan and East Africa.
Our Vision of Aga Khan University Ho...
Read more about this company
Manager, Research Administration, Clinical Research Unit
The Clinical Research Unit is seeking a Manager, Regulatory Affairs and Data Management (Research Administration), 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 Ethics and Regulatory Authority submissions for new and ongoing clinical trials (new protocols, informed consent forms, site specific addendums, study manuals, amendments, safety reports, protocol deviations, annual reports, etc.) to entities such as Ethics Committee (EC), Pharmacy and Poisons Board (PPB), National Commission of Science, Technology, Innovation (NACOSTI), etc.
Development and maintenance of investigator site files, including maintaining all staffs’ training documentation and certifications.
Coordinating the preparation of and training on SOPs and maintaining the review cycle.
Assist the investigators and study team in the development and review of study documents (study tools such as source documents, study logs, etc.).
Maintain up-to-date understanding of the EC, PPB, NACOSTI, 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).
Oversee all aspects of Data Management, including data entry and query resolution processes and outcomes (timelines, accuracy, etc.)
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.
Gmail
Yahoomail