The Global Trial Operations (GTO) Manager leads the strategic planning, execution, and ongoing optimization of global clinical trials. This role integrates feasibility strategy and operational leadership with advanced data analysis, cross-functional collaboration, and alignment across the enterprise. The GTO Manager plays a critical role in delivering high-performing, patient-centric trials by aligning scientific objectives with operational strategies, real-world data insights, and commercial goals.
Responsabilities and tasks:
- Lead portfolio-wide feasibility strategy and optimization efforts across studies, ensuring timely enrollment and risk-adjusted planning.
- Oversee enrollment forecasting using internal tools and collaborate with study teams on re-forecasting when performance trends deviate.
- Perform root cause analysis for underperforming trials and recommend optimized country and site scenarios in coordination with the Feasibility team.
- Develop scalable methodologies for global site selection aligned with patient access, regulatory readiness, and future commercialization potential.
- Contribute strategic input during indication and country allocation planning to enhance portfolio execution.
- Embed trial optimization into early clinical development discussions to improve long-term success rates.
- Partner with Commercial Business Information Services to integrate real-world data and enterprise analytics into feasibility and site planning.
- Provide robust data intelligence packages on indication landscape, recruitment benchmarks, trial competition, and market trends.
- Stay current with AI/ML trends and drive innovation through the application of predictive analytics and optimization algorithms.
- Establish and monitor key performance indicators (KPIs) to measure the impact of trial optimization initiatives and continuously refine approaches.
- Align with IT and systems stakeholders to ensure enrollment forecasting integrates into enterprise planning platforms and data lakes.
- Collaborate with internal and external vendors to ensure tools, systems, and methodologies are optimized for trial execution.
- Develop standardized SOPs and workflows that govern data use, feasibility processes, and optimization frameworks.
- Lead change management efforts to embed data-driven optimization practices across clinical teams and therapeutic areas.
- Provide training and oversight for business users on new forecasting tools, dashboards, and system enhancements.
- Champion adoption of new tools and methodologies, fostering a culture of continuous improvement.
- Mentor and lead a global team responsible for optimization initiatives.
- Support team development through performance coaching, growth planning, and cross-functional collaboration opportunities.
Requirements:
- Bachelor’s or Master’s degree in Life Sciences, Public Health, Biostatistics, or related field; PhD/MD/PharmD a plus.
- Senior Manager Level with 12+ years of experience in clinical development or clinical operations, with at least 5 years in a global strategic leadership role.
- Associate Director Level 20+ years of experience in clinical development or clinical operations, with at least 10 years in a global strategic leadership role.
- Minimum 1 year of experience managing direct reports and leading cross-functional initiatives.
- Proven experience with country and site selection, feasibility assessments, and enrollment planning.
- Strong knowledge of real-world data tools (e.g., CTMS, Citeline, TA Scan, TriNetX, H1) and other analytics platforms.
- Demonstrated ability to lead portfolio-level planning and integrate operations with commercial strategy.
- Expertise in business intelligence, data lake architecture, and system integrations.
- Strong communication, stakeholder engagement, and problem-solving skills.
- Demonstrated ability to drive innovation, continuous improvement, and scalable operational excellence.
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.
At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.