Senior Manager, Clinical Trial Start-Up

Job Summary

A company is looking for a Senior Manager, Clinical Trial Study Start-Up.

Key Responsibilities

• Lead and manage end-to-end start-up activities for assigned clinical trials, including regulatory submissions and site readiness
• Establish operational objectives and oversee start-up deliverables for SSU staff or CRO partners
• Provide expert input into budget planning, timelines, and resource recommendations for study start-up execution

Required Qualifications, Training, and Education

• Bachelor's degree in life sciences or related field; advanced degree preferred
• 5+ years of experience in operational clinical research, including 3+ years in study start-up operations and team leadership
• Strong operational understanding of global regulatory requirements and site activation pathways
• Proficiency in clinical systems such as CTMS, eTMF, and Veeva Vault
• Experience supporting audits and regulatory inspections related to start-up activities