Clinical Program Manager Resume Example

Clinical Program Manager · IQVIA

San Diego, CA · 2018 - Present

• Led a portfolio of 5 global oncology and rare disease clinical programs (Phase II/III) simultaneously, managing budgets exceeding $75M annually and overseeing teams of 30+ cross-functional personnel.
• Implemented standardized operational processes across 15+ countries, reducing study start-up times by 20% and improving overall data quality by 15% through enhanced monitoring strategies.
• Successfully guided 3 programs through key regulatory milestones, including submitting CTA/IND amendments and achieving successful End-of-Phase II meetings with the FDA and EMA.
• Developed and executed decentralized clinical trial (DCT) strategies for 2 programs, resulting in a 25% increase in patient retention and a 30% reduction in site monitoring costs.
• Negotiated and managed complex contracts with 50+ vendors, achieving 10% cost savings while maintaining high-quality service delivery for clinical operations.

Senior Clinical Project Manager · PPD (now Thermo Fisher Scientific Clinical Research)

Morrisville, NC · 2014 - 2018

• Managed 8 Phase I/II clinical trials in immunology and infectious diseases, ensuring adherence to ICH-GCP guidelines and protocol requirements from initiation to close-out.
• Achieved 100% on-time delivery for all major study milestones across a portfolio of studies, managing budgets totaling $30M with a variance of less than 3%.
• Mentored and provided leadership to a team of 15+ Clinical Research Associates and Clinical Trial Assistants, fostering a high-performance and compliant work environment.
• Streamlined data review and query resolution processes, reducing the database lock cycle time by 18% for multiple studies through proactive communication with data management and sites.
• Presented program updates and strategic recommendations to executive leadership and sponsors, consistently receiving positive feedback for clarity and actionable insights.

Clinical Project Manager · Medpace

Cincinnati, OH · 2012 - 2014

• Oversaw the execution of 4 early-phase cardiovascular trials, coordinating activities across multiple sites in North America and Europe.
• Managed day-to-day operational aspects, including vendor selection, budget tracking, and resource allocation, ensuring projects stayed within scope and on schedule.
• Improved site selection and activation efficiency by 10% through the implementation of a new centralized documentation process.
• Facilitated effective communication between sponsors, investigators, and internal teams, resolving issues promptly to maintain study progress.
• Contributed to the development of trial protocols, informed consent forms, and case report forms, ensuring regulatory compliance and scientific integrity.

Ph.D. in Pharmaceutical Sciences · University of California, San Francisco

San Francisco, CA · 2008 - 2012

• Dissertation: 'Pharmacokinetic Modeling of Novel Immunotherapies for Oncology Applications'
• Published 3 peer-reviewed articles in high-impact pharmacology journals
• Awarded Dean's Scholarship for outstanding academic achievement

Bachelor of Science in Biomedical Engineering · University of California, Berkeley

Berkeley, CA · 2004 - 2008

• Graduated Magna Cum Laude, GPA: 3.8/4.0
• Senior thesis on 'Development of Biosensors for Real-time Drug Monitoring'
• President of the Biomedical Engineering Society student chapter

Clinical Program Manager · Amgen

Thousand Oaks, CA · 2019 - Present

• Led a global Phase III oncology program with 150+ sites and 1,200 patients, achieving 95% on-time enrollment targets and successful primary endpoint readout.
• Managed a $25M annual program budget, identifying and implementing cost-saving measures that reduced operational expenses by 10% without impacting quality.
• Spearheaded the development and implementation of a new electronic Trial Master File (eTMF) system, improving document submission efficiency by 20% across multiple trials.
• Directed cross-functional teams of 30+ members including medical, regulatory, biostatistics, and operations, fostering a collaborative environment that improved team productivity by 15%.

Clinical Project Manager · Neurogenetics Inc.

San Diego, CA · 2016 - 2019

• Managed two Phase I/II neurology trials from study start-up to close-out, ensuring adherence to ICH GCP and FDA regulations for all trial activities.
• Oversaw vendor selection and management for CROs, central labs, and IRBs, negotiating contracts that resulted in an average 8% cost reduction per trial.
• Developed and implemented risk management plans, proactively identifying and mitigating potential study delays, leading to 98% on-time milestone delivery.
• Presented study progress and key data readouts to senior leadership and regulatory bodies, contributing to successful IND amendment submissions.

Senior Research Scientist, Translational Medicine · Scripps Research Institute

La Jolla, CA · 2012 - 2016

• Designed and executed complex molecular biology experiments to identify novel biomarkers, resulting in the discovery of 2 potential therapeutic targets.
• Managed a team of 3 junior researchers, providing mentorship and technical guidance that improved experimental throughput by 25%.
• Collaborated with pharmaceutical partners on preclinical drug discovery projects, contributing to the successful transfer of 1 compound into early-phase clinical development.
• Authored 5 scientific reports and presented findings at 4 international conferences, enhancing the institute's reputation in neurodegenerative research.

Ph.D. in Molecular Biology · University of California, San Diego

La Jolla, CA · 2007 - 2012

• Thesis: 'Genomic Markers in Neurodegenerative Diseases' focused on early detection strategies.
• Published 3 peer-reviewed articles in high-impact scientific journals.
• Awarded Dean's Fellowship for outstanding academic achievement and research potential.