Overview
The Sr/Assistant Manager will support the institutional research governance operations within the Clinical Research & Innovation Office.
This role serves as a key contributor to maintaining high standards of research integrity and quality across clinical research activities.
Core Functions Include
- Conduct study monitoring visits and review study documentation, assess protocol adherence and working with research teams to support the success and improving quality of studies.
- Conduct compliance checks across research operations, identifying compliance gap, providing feedback to stakeholders on findings and recommendations.
- Support institutional audits, inspections and accreditation activities.
- Identify gaps and drive improvement initiatives to enhance the quality of research studies and strengthen internal processes
- Supporting sponsor oversight responsibilities and institutional quality management of clinical trials to ensure compliance with sponsor obligations and regulatory requirements.
- Provide regulatory advice and liaise with internal stakeholders for timely regulatory submissions
- Drive outreach activities to educate staff and research teams, to promote the culture of proper conduct of research
- Collect and compile data for management reporting
- Manage operations of institutional research governance and administration.
Preferred Experience And Skills
- Relevant degree in Life Sciences, Pharmacy, Nursing, or healthcare related field
- Experience in monitoring of research studies
- Familiar with ICH-GCP E6 guidelines, IRB and local regulatory requirements
- Meticulous, flexible, has strong organizational skills and able to work independently
- Strong presentation and communication skills with stakeholders, including clinical staff, management, and auditors
