Senior Global Clinical Study Manager

Location: New York

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.

Required Experience2+ 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

Job Overview 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.

Key Responsibilities Global Study & Site Leadership 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

Project & Stakeholder Management 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

Operational Excellence & Risk Management 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

Financial & Contract Management 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)
Quality & Compliance Maintain TMF health and ensure timely document submission

Develop quality monitoring plans and compliance metrics

Ensure adherence to study tools, training materials, and processes

Team Leadership & Development 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

Qualifications Required Bachelor ’s degree in life sciences or related field5+ 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

Core Competencies Exceptional communication and stakeholder management skills

Strong problem-solving and risk mitigation capabilities

Ability to influence without authority in matrix organizations

High attention to detail and quality-driven mindset

Proficiency in Microsoft Office and clinical systems (e.g., CTMS, EDC)
Why Join UsWork on cutting-edge global trials across therapeutic areas

Collaborate with top talent in a dynamic, global environment

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