Durham, North Carolina, United States of America
4 hours ago
Senior Global Clinical Study Manager

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 ResponsibilitiesGlobal Study & Site LeadershipLead site management strategy from study award through close-outOversee site identification, selection, activation, and recruitment performanceEnsure clinical monitoring processes meet study needs and timelinesPartner with CRAs to optimize enrollment, data quality, and complianceProject & Stakeholder ManagementServe as primary client contact and own key customer relationshipsLead cross-functional teams across regions and culturesFacilitate internal and external meetings, including executive presentationsDrive collaboration across stakeholders, vendors, and functional leadsOperational Excellence & Risk ManagementDevelop and manage integrated study plans and risk mitigation strategiesProactively identify risks and implement corrective/preventative actionsMonitor study timelines, enrollment trends, and data quality metricsEnsure compliance with GCP, SOPs, protocols, and regulatory standardsFinancial & Contract ManagementManage study financials, including forecasting and revenue accelerationIdentify and manage out-of-scope work and change ordersOversee Billing Unit Reviews (BURs) and expense approvalsTrack performance against budget and Estimate at Completion (EAC)Quality & ComplianceMaintain TMF health and ensure timely document submissionDevelop quality monitoring plans and compliance metricsEnsure adherence to study tools, training materials, and processesTeam Leadership & DevelopmentLead and mentor cross-functional project teamsSupport CRA and team training on therapeutic areas and study-specific needsFoster collaboration, knowledge sharing, and continuous improvementQualificationsRequiredBachelor’s degree in life sciences or related field5+ years of clinical research/monitoring experience, including 2 years in a clinical study management roleStrong knowledge of ICH-GCP, FDA regulations, and clinical trial processesExperience managing global clinical trials and multi-regional teamsDemonstrated experience in project financial managementCore CompetenciesExceptional communication and stakeholder management skillsStrong problem-solving and risk mitigation capabilitiesAbility to influence without authority in matrix organizationsHigh attention to detail and quality-driven mindsetProficiency in Microsoft Office and clinical systems (e.g., CTMS, EDC)Why Join UsWork on cutting-edge global trials across therapeutic areasCollaborate with top talent in a dynamic, global environmentMake 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.
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