Clinical Study Manager, Clinical Operations

Responsibilities

• Lead the operational planning, execution, and management of one or more Phase 1-3 global clinical trials.
• Manage vendor selection, contracting, and oversight of CROs and third-party vendors to ensure compliance with timelines and budget.
• Coordinate clinical study timelines and budgets in collaboration with Global Project Management and R&D Finance.
• Identify, mitigate, and escalate risks throughout the study lifecycle, ensuring they are logged in the risk management system.
• Oversee site selection, start-up, monitoring, and closeout processes.
• Ensure strict compliance with GCP/ICH guidelines and other regulatory requirements (FDA, MHRA, etc.).
• Support inspection readiness, audit activities, and ensure the Trial Master File is complete and accurate.
• Oversee data cleaning metrics, including EDC data entry and query resolution.

Requirements

• Bachelor's Degree in Life Sciences is required.
• 3 or more years of experience in clinical trial oversight.
• Proven experience with the oversight of global clinical trials across all phases and stages of delivery.
• Strong knowledge of GCP/ICH guidelines and regulatory requirements.
• Extensive experience in vendor and CRO management.
• Ability to travel up to 10% of the time.

Preferred Qualifications

• Experience as a Clinical Research Associate (CRA).
• Experience working in a medical environment, such as a Study Site Coordinator.
• Experience within a pharmaceutical company, medical device company, or Contract Research Organization (CRO).
• Familiarity with Japan-based organizations.

About the Company

Daiichi Sankyo, Inc. is a global healthcare company dedicated to improving lives through innovative medicines. With a legacy dating back to 1899, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders to shape a healthier, more hopeful future for patients worldwide.