Global Study Program Lead

Parexel International; North Carolina; Hybrid; USD 120,000 - 160,000; Full time

Job summary

Parexel is seeking a Global Study Manager II to provide operational leadership across the study lifecycle, oversee study management and site activities, and coordinate with CROs and vendors. You will drive study start-up, monitoring, and training plans, manage budgets and vendor costs, and support inspection readiness to ensure timely, high-quality data delivery.

The role requires significant experience in clinical trials, strong program management skills, and the ability to collaborate with

Qualifications

• Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operational clinical trial experience.
• Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience.
• A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology

Responsibilities

• Leads and coordinates the execution of a clinical trial globally from sourcing strategy through fully outsourced studies and vendor deliverables.
• Provides quality oversight and coordination of regional and country operations and CRO tasks related to study execution.
• Leads recruitment targets and milestones as the single point of accountability for start up, monitoring and other study level plans.
• Drives decision making with the CSTL to provide input to operational strategy.
• Ensures development of study level plans, monitoring and training plans, and approves study documents and guidelines.
• Oversees drug supply management and sets up interactive randomization systems with supply chain lead.
• Manages vendor oversight, cost variance, invoices, and POs to align with forecast.
• Reviews study level metrics and analytics and mitigates risks.
• Leads protocol deviation review and supports inspection readiness activities.
• Ensures TMF setup for study management and country/site level documents.

Job description

Parexel is seeking a Global Study Manager II to provide operational leadership across the study lifecycle, oversee study management and site activities, and coordinate with CROs and vendors. You will drive study start-up, monitoring, and training plans, manage budgets and vendor costs, and support inspection readiness to ensure timely, high-quality data delivery.

The role requires significant experience in clinical trials, strong program management skills, and the ability to collaborate with