Work Schedule: Standard (Mon‑Fri)

Environmental Conditions: Office

• Manage all clinical operational and quality aspects of assigned studies of moderate to high complexity in compliance with ICH GCP.
• Develop clinical tools such as Monitoring Plans and Guidelines in conjunction with the Data Quality Plan, and contribute to the Master Action Plan for clinical documents.
• Ensure timely setup, organization, content, and quality of the relevant sections of the Trial Master File (local and central) and participate in the design and development of CRFs and related documents as required.
• Collaborate with the clinical team and other departments to meet deliverables, communicate regularly, and manage team meetings to maintain timelines, resources, interactions, and quality.
• Implement and train standardized clinical monitoring pro...