Study Management Associate III

Study Oversight and Leadership:

• Provide study-level oversight and leadership for global trials, from inception through closure.
• Facilitate stakeholder engagement, drive deliverables, and ensure timely documentation at the study level.
• Ensure inspection readiness and participate in related activities.

Risk Management:

• Identify, mitigate, and manage risks, including timely issue review and escalation.
• Support trend analysis and risk prevention.
• Review and manage study materials, including protocols, regulatory submissions, and training materials.

System Management:

• Ensure CTMS and eTMF management to facilitate compliance and support timelines.
• Participate in user acceptance testing for EDC, IRT, and ePRO systems.
• Manage investigational product and other associated study supplies.