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Clinical Study Start-Up Manager

2 months ago


San Francisco, California, United States Daiichi Sankyo, Inc. Full time
Job Title: Clinical Study Start-Up Manager

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.