Senior Manager, Clinical Trial Start-Up

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