Global Study Lead - End-to-End Trial Operations

Parexel; United States; Remote; USD 110,000 - 170,000; Full time

Job summary

Parexel is seeking a Global Study Manager II to lead study management from startup through database release, coordinating sites, vendors, and pCROs to ensure high-quality, timely data across global trials.

You will partner with cross-functional teams, develop plans, monitor budgets, manage risk, and mentor junior staff, delivering on time with compliance to GCP and regulatory requirements.

Qualifications

• Bachelor's degree in life sciences or related field required, with 7+ years in operational clinical trials.
• Master's degree or MBA with 6+ years of relevant experience preferred.
• Extensive knowledge of study management processes and GCPs.

Responsibilities

• Lead the execution of global studies from startup to database release with vendor oversight.
• Coordinate SOMs, pCROs, sites, and cross-functional teams to meet timelines and budgets.
• Develop plans, risk management, and inspection readiness for study management.
• Mentor SOMs and GSMs; ensure TMF setup and regulatory compliance.
• Monitor budget, contracts, and per-subject costs; drive issue resolution.

Skills

Study management

Vendor oversight

Leadership

Cross-functional collaboration

Communication skills

English fluency

Education

Bachelor's degree in a related field

Master's degree or MBA (preferred)

Job description

Parexel is seeking a Global Study Manager II to lead study management from startup through database release, coordinating sites, vendors, and pCROs to ensure high-quality, timely data across global trials.

You will partner with cross-functional teams, develop plans, monitor budgets, manage risk, and mentor junior staff, delivering on time with compliance to GCP and regulatory requirements.