Study Start Up and Operations Project Manager

Job Summary

A company is looking for a Study Operations Manager / Study Start Up Project Manager for their Clinical Trials team.

Key Responsibilities:

• Oversee study startup deliverables at a country level, including implementation of start-up and site activation plans, recruitment strategy, and regulatory submissions
• Manage the study start-up process in assigned countries, ensuring compliance with project plans and quality standards
• Provide country-level input on start-up and recruitment milestones, communicate bidirectionally between global and local study teams, and identify trends to improve start-up processes

Required Qualifications:

• Operational clinical trial experience and knowledge of Good Clinical Practice and regulatory operations
• 5+ years of clinical research experience and/or study management/start-up project manager experience
• Experience leading cross-functional teams and working in a matrix management environment
• Bachelor's or Master's degree in a relevant field
• Scientific or technical degree preferred