Manager, CSAR - Global Library Manager - Remote

Overview

The Global Library Manager at Amgen will support Global Library activities, ensuring adherence to Data Element Standards and providing database design services for clinical studies.

In Short

• Manage Global Library activities for clinical studies.
• Coordinate with Lead Data Manager for Data Element Standards.
• Provide database design services aligned with company standards.
• Maintain standard CRFs and Edit checks in CDMS (RAVE).
• Support clinical trial platform technologies.
• Act as a data scientist to provide analytical insights.
• Develop and implement policies and SOPs.
• Assist in audit preparations and responses.
• Lead large system transformation projects.
• Ensure compliance with regulatory bodies.

Requirements

• Master’s degree in life science, computer science, or related field with 4-6 years experience.
• Bachelor’s degree with 6-8 years of experience.
• Diploma with 10-12 years of experience.
• Experience in data management/programming in the Pharmaceutical or Biotech sector.
• General project management experience.
• Knowledge of Good Clinical Practice.
• Experience with clinical database management systems.
• Understanding of CDISC and SDTM.
• Strong analytical and problem-solving skills.
• Experience in oversight of outside vendors.

Benefits

• Competitive salary and comprehensive Total Rewards Plans.
• Support for professional and personal growth.
• Collaborative culture focused on innovation.
• Inclusive environment respecting diverse backgrounds.
• Commitment to employee well-being.