Leena Mathew
Downingtown
Summary
Results-driven Program Manager with a strong track record in optimizing clinical trials across multiple therapeutic areas. Reduced study start-up timelines by 15% and protocol deviations by 30%, enhancing overall client satisfaction by 20%. Expert in leading cross-functional teams and managing complex trial lifecycles across 50+ global sites.
Overview
18
18
years of professional experience
Work History
Program Manager (Clinical)
Ocugen, Inc.
Malvern
05.2025 - Current
- Work alongside the clinical operations team helping to translate clinical strategy into detailed project plans.
- Developed project charts incorporating key strategic assumptions from clinical sites and cross-functional dependencies.
- Analyzed, planned, and tracked project activities on a regular basis; proactively identified and resolved operational challenges from different clinical sites and minimized delays that may impact cross-functional teams.
- Created a monitoring chart for each clinical trial (all the projects) and updated those charts on a a regular basis as agreed with the management team.
- Shared chart updates with PMO and Head of clinical to ensure alignment and transparency.
- Managed alliances with clinical sites to ensure effective collaboration.
- Track critical path tasks and identify project risks during various stages of clinical operations/development.
- Communicated of risks to relevant stakeholders.
- Work with external CRO or vendor(s) to track project timelines and monitor KPIs.
- Coordinate functional project teams and take full accountability of deliverables, balancing quality and timeliness.
- Ensure fluid project communication and report project status to project and program leadership.
- Implement best practices across project teams e.g., resource capacity planning, project risk management, team performance, timeline development, portfolio management.
- Work with functional leaders to ensure positive team spirit and high functioning team.
- Contributed to development of project management tools, templates, and processes to streamline operations.
- Tracked spending versus budget projections and identified resource needs.
Senior Project Manager
ICON
Bluebell
04.2024 - 04.2025
- Led global clinical trial programs across multiple countries and 50+ sites, managing end-to-end lifecycles from start-up to close-out.
- Managed trial budgets and contracts, maintaining financial health and ensuring compliance with fiscal accountability standards.
- Acted as primary client contact, facilitating kick-off, investigator, and team meetings, and providing comprehensive project status reports to stakeholders.
- Ensured timely, within-budget delivery while maintaining compliance with ICH-GCP, GLP, and 21CFR Part 11 regulations.
- Collaborated with statistics vendors, data management teams, and medical writers to produce high-quality data and ensure accurate reporting for clinical trials.
- Reduced study start-up timelines by 15% and protocol deviations by 30% through standardized processes.
Clinical Project Manager
ICON
Bluebell
11.2021 - 03.2024
- Coordinated multidisciplinary clinical trial programs, leading global teams across diverse sites to successfully deliver Phases I-III trials.
- Acted as client liaison, ensuring clear communication of project updates and scope changes, achieving 20% higher client satisfaction.
- Achieved a 98% query resolution rate near database lock through effective cross-functional collaboration.
- Mentored junior project managers, enhancing team performance and adherence to SOPs.
- Collaborated with stats vendors, data management, and medical writing teams to enhance trial processes and reporting.
Sr. Clinical Research Program Manager
Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center
11.2019 - 10.2021
- Facilitated seven clinical trials that resulted in marketing approval of Mepolizumab, demonstrating commitment to scientific integrity.
- Led oncology clinical research programs, ensuring regulatory compliance and optimizing data collection for Phases II-III trials.
- Increased patient recruitment by 25% in the SPARK trial through innovative site engagement strategies.
Clinical Research Program Manager
Johns Hopkins University School of Medicine
02.2008 - 11.2019
- Managed respiratory clinical trials (Phases II-III), contributing to successful marketing of Mepolizumab.
- Coordinated cross-functional teams to deliver trials on time and within budget, ensuring adherence to ICH-GCP and SOPs.
- Supported regulatory inspections, achieving a 100% audit pass rate.
Education
Masters - Project Management
Morgan State University
Maryland01-2019
Bachelors - Molecular Biology, Biochemistry & Bioinformatics
Towson University
Maryland01-2008
Skills
- Clinical trial management and regulatory compliance
- Compliance monitoring and risk assessment
- Cross-functional collaboration and team leadership
- Stakeholder communication and process optimization
- Strategic thinking and conflict resolution
- Multi-operations management and change management
- Process improvement in agile projects
- Program oversight
Professional Memberships And Certifications
- Certified Clinical Research Professional (CCRP), Society of Clinical Research Associates
- Certified Associate in Project Management (CAPM), Project Management Institute
Expertise Summary
Results driven and Focused Senior Clinical Project Manager with over 17 years of experience leading global clinical trials (Phases I-III) in Respiratory, Oncology, Immunology and Opthalmology therapeutic expertise, resulting in successful drug approvals, strategic and operational efficiencies. Proven expertise in managing full trial lifecycles from start-up to close-out, ensuring compliance with ICH-GCP, and local regulations. Skilled in overseeing large, multidisciplinary teams across 50+ global sites, managing budgets, and fostering strong stakeholder relationships. Achieved a 15% reduction in study start-up timelines and a 30% decrease in protocol deviations, boosting client satisfaction by 20%.
Timeline
Program Manager (Clinical)
Ocugen, Inc.
05.2025 - Current
Senior Project Manager
ICON
04.2024 - 04.2025
Clinical Project Manager
ICON
11.2021 - 03.2024
Sr. Clinical Research Program Manager
Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center
11.2019 - 10.2021
Clinical Research Program Manager
Johns Hopkins University School of Medicine
02.2008 - 11.2019
Masters - Project Management
Morgan State University
Bachelors - Molecular Biology, Biochemistry & Bioinformatics
Towson University