Sr/ Assistant Manager (Compliance and Monitoring) (1-year contract renewable)

Family Group: Administration

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