Sr/ Assistant Manager (Compliance and Monitoring)
Tan Tock Seng HospitalJob 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 - Meticulous, flexible, has strong organizational skills and able to work independently - Strong presentation and communication skills with stakeholders, including clinical staff, management, and auditors This is 1-year contract renewable.
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