Senior Global Clinical Study Manager

IQVIA; Dallas (TX); Vor Ort; USD 93.000 - 233.000; Vollzeit

Zusammenfassung

IQVIA is seeking a Global Study Manager to lead end-to-end site management for global oncology trials. You will activate sites, monitor performance, and ensure quality and compliance across regions, serving as the primary client contact and coordinating cross-functional teams.

Responsibilities include developing integrated study plans, managing timelines and budgets, and upholding ICH-GCP standards while driving enrollment and risk mitigation in a fast-paced, global environment.

Qualifikationen

• 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.

Aufgaben

• Lead site management strategy from study award through close-out.
• Oversee site identification, activation, and recruitment performance.
• Serve as primary client contact and own key customer relationships.
• Develop integrated study plans and risk mitigation strategies.

Kenntnisse

Global study leadership

Cross-regional collaboration

ICH-GCP knowledge

Client relationship management

Ausbildung

Bachelor’s degree in life sciences or related field

Tools

CTMS

EDC

Microsoft Office

Jobbeschreibung

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.

Required Experience

• 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

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 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

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 Us

• Work on cutting-edge global trials across therapeutic areas
• Collaborate with top talent in a dynamic, global environment
• Make a direct impact on patient outcomes worldwide

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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