Job Description

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

For interested candidates, please send your most recent and updated resume to [Confidential Information]

Tsin Chien Yee Sally
R25127272
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