Senior Global Clinical Study Manager

Durham, North Carolina, United States of America

Phoenix, AZ, United States of America

Gilbert, AZ, United States of America

San Francisco, CA, United States of America

New York, NY United States of America

Indianapolis, Indiana, United States of America

Tampa, FL, United States of America

Rockville, Maryland, United States of America

Chicago, Illinois, United States of America

Dallas, Texas, United States of America

Full time

R1553750

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.

Drive global clinical trials from first site activation to final patient visit—own the strategy, accelerate delivery, and shape the future of clinical research worldwide.

• 2+ years of global study management experience

• Experience across multiple countries/regions

• Phase I–III clinical trials experience (Phase III required)

• Oncology experience required

• Ability to work across multiple therapeutic areas

We are seeking a Global Study Manager responsible for the end-to-end planning, execution, and delivery of clinical trial site management activities across global studies. This role ensures successful site selection, activation, monitoring oversight, and closeout—while balancing speed, quality, and cost. You will serve as the primary point of contact for clients , lead cross-functional teams, and ensure compliance with ICH-GCP, regulatory requirements, and study protocols .

This is a highly visible role that combines strategic leadership, operational execution, and financial oversight .

• Lead site management strategy from study award through close-out

• Oversee site identification, selection, activation, and recruitment performance

• Ensure clinical monitoring processes meet study needs and timelines

• Partner with CRAs to optimize enrollment, data quality, and compliance

• Serve as primary client contact and own key customer relationships

• Lead cross-functional teams across regions and cultures

• Facilitate internal and external meetings, including executive presentations

• Drive collaboration across stakeholders, vendors, and functional leads

• Develop and manage integrated study plans and risk mitigation strategies

• Proactively identify risks and implement corrective/preventative actions

• Monitor study timelines, enrollment trends, and data quality metrics

• Ensure compliance with GCP, SOPs, protocols, and regulatory standards

• Manage study financials, including forecasting and revenue acceleration

• Identify and manage out-of-scope work and change orders

• Oversee Billing Unit Reviews (BURs) and expense approvals

• Track performance against budget and Estimate at Completion (EAC)

• Maintain TMF health and ensure timely document submission

• Develop quality monitoring plans and compliance metrics

• Ensure adherence to study tools, training materials, and processes

• Lead and mentor cross-functional project teams

• Support CRA and team training on therapeutic areas and study-specific needs

• Foster collaboration, knowledge sharing, and continuous improvement

• Bachelor’s degree in life sciences or related field

• 5+ years of clinical research/monitoring experience, including 2 years in a clinical study management role

• Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes

• Experience managing global clinical trials and multi-regional teams

• Demonstrated experience in project financial management

• Exceptional…