Global Trial Optimization Manager

Job Summary
We are seeking a Global Trial Optimization Manager to join our team and contribute to the planning, execution, and optimization of clinical trials. This role involves analyzing data, identifying key insights, and implementing strategies to maximize the efficiency and effectiveness of trials across various departments.

Key Responsibilities:

Trial Planning/Optimization Strategies:

• Review enrollment to ensure timely progress toward company milestones, and re-forecasting when trending out of bounds.  
• In collaboration with individual study teams, perform root cause analysis for underperforming enrollment and present alternative country/site scenarios in collaboration with Feasibility team members. 
• Monitor trial data to identify patterns, challenges, and optimization opportunities.
• Utilize statistical tools to analyze trial performance and recommend adjustments.

Data Analysis & Insights:

• Collaborate with Commercial Business Information Services to ensure maximum utilization of enterprise-wide real world data sources.
• Provide study team with Comprehensive data intelligence packages including information on indication, competitive landscape, recruitment timelines, drug pipeline, etc
• Remain abreast with industry leading trends in applicable data sources, Artificial Intelligence, and Machine Learning applications to maintain strategic competitive advantage.  

Reporting & Documentation:

• Prepare and present trial performance reports to key stakeholders.
• Ensure that trial documentation is comprehensive, clear, and compliant with relevant regulations (e.g., GxP, FDA).
• In collaboration with Business Intelligence, design user-centric dashboards and visualizations to broadcast country and site enrollment data to leadership for transparent communication and strategic decision making

Collaboration & Stakeholder Engagement:

• Collaborate with internal partners to identify systems reliant upon accurate enrollment forecasting and facilitate necessary data integrations, in collaboration with IT Business Partners, to create strategic alignment across the enterprise.
• Engage with external partners or vendors to enhance trial quality or efficiency.

Training & Implementation:

• Responsible for training of business end users and roll out of any enhancements to the system
• Draft and finalize SOP/WI with the assistance of key stakeholders to ensure a standardize approach to how users utilize the system. 

Leadership:

• Hire, manage and support direct reports in the completion of the above outlined tasks. 
• Support career development, goal setting and growth opportunities.

Qualifications:

• Bachelor’s or master’s degree and 5+ years of pharmaceutical experience and 1 year of direct report experience. 
• Comprehensive understanding of the clinical development process and cross functional departmental roles and responsibilities.
• Deep understanding of real-world data sources used for country and site selection, including CTMS, CITELINE, TASCAN, H1, TriNetX.
• Direct experience with country selection, site identification, feasibility and selection.
• Expertise in the development of Business Intelligence, data lake structure, and systems Integrations.
• Ability to develop innovative approaches for enhanced strategic alignment and drive implementation.     

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