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Clinical Study Start-Up Manager
2 months ago
About the Role:
Daiichi Sankyo, Inc. is seeking a highly skilled Clinical Study Start-Up Manager to join our team. As a key member of our PV Safety Operations department, you will be responsible for driving global Clinical Study Start-Up activities.
Key Responsibilities:
- Develop and maintain SAE Flow Plans and electronic data capture (EDC) Safety report outputs
- Review clinical study protocols and the Clinical Study Oversight Plan
- Manage day-to-day operations of the DS Safety Notification Letter (SNL) System and uploads to TMF activities
- Interact with global study teams and represent PV operations in global interactions with CS Physicians and other study team members
Requirements:
- Bachelor's Degree in Science required
- 4 or more years of drug safety experience with technical experience in Electronic Data Capture and Safety Reporting preferred
- 7 or more years of MS, RN, or PharmD preferred, or total pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferred
About Daiichi Sankyo, Inc.:
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. We are committed to diversity and inclusion in the workplace.