Senior Global Clinical Study Manager
IQVIA · Durham, United States +9 · 3mo ago
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.