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Job Summary
We are seeking a Global Sr Trial Optimization Specialist 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:
- Using enrollment forecasting tool, 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:
- Provide study team with Comprehensive data intelligence packages including information on indication, competitive landscape, recruitment timelines, drug pipeline, etc
- 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).
- 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:
- Support training of business end users and roll out of any enhancements to the system
- Support drafting and finalization SOP/WI with the assistance of key stakeholders to ensure a standardize approach to how users utilize the system
Qualifications:
- Bachelor’s or master’s degree and 3-4 years of pharmaceutical 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.
- 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
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