Sr/ Assistant Manager (Compliance and Monitoring)

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