Open to opportunities

Juan Garcia Ballarati

@juangarciaballarati

Clinical technology operations and program management leader delivering GxP-compliant eClinical platforms with data-driven, global execution.

United States

Message

What I'm looking for

I’m looking to lead clinical technology operations and program delivery—driving GxP-compliant SaaS transformations, KPI-driven performance, and audit-ready execution with strong cross-functional teams and customer outcomes.

Global, results-driven leader with track record of advancing life sciences operations across pharmaceutical, biotech, CRO, and healthcare organizations.

I lead technology, operations, and program teams transforming clinical trial execution, leveraging technology to drive measurable outcomes.

My experience spans the delivery of SaaS platforms (eCOA, RIM, EDC, eConsent, ePRO, EHR, RTA), overseeing $80M+ portfolios and directing 50+ people global cross-functional professionals across 200+ GxP-compliant clinical studies from Phase I to Phase IV across different therapeutic areas. I bring a hands-on, data-driven leadership approach that fosters cross-functional collaboration, and process optimization. I build high-performing, customer-centric teams grounded in accountability, promoting an entrepreneurial mindset that accelerates time to market while maintaining high-quality outputs.

🏅𝐀𝐂𝐇𝐈𝐄𝐕𝐄𝐌𝐄𝐍𝐓𝐒:

💉 𝐂𝐎𝐕𝐈𝐃-19 𝐕𝐚𝐜𝐜𝐢𝐧𝐞 𝐃𝐞𝐥𝐢𝐯𝐞𝐫𝐲: Led technical delivery of the eCOA platform for the first FDA-approved COVID-19 vaccine in 6 weeks, 50% faster than standard timelines, supporting 45,000 participants globally, resulting in a 600% growth in the vaccine portfolio account with a top U.S.-based pharmaceutical company.

📊 𝐏𝐨𝐫𝐭𝐟𝐨𝐥𝐢𝐨 𝐋𝐞𝐚𝐝𝐞𝐫𝐬𝐡𝐢𝐩 𝐚𝐭 𝐒𝐜𝐚𝐥𝐞: Directed $50M RIM/EDC portfolios supporting 100+ active studies for top 10 pharma sponsors, and a $20M eCOA/ePRO portfolio spanning 60+ concurrent Phase II–IV studies.

💵 𝐂𝐨𝐬𝐭 𝐎𝐩𝐭𝐢𝐦𝐢𝐳𝐚𝐭𝐢𝐨𝐧: Delivered $3M in savings by decommissioning 20+ studies and consolidating authentication platforms across 60+ studies for 5 customers in under 10 weeks.

☁️ 𝐂𝐥𝐨𝐮𝐝 𝐌𝐢𝐠𝐫𝐚𝐭𝐢𝐨𝐧 & 𝐌𝐨𝐝𝐞𝐫𝐧𝐢𝐳𝐚𝐭𝐢𝐨𝐧: Migrated 10+ top pharma Regulatory Information Management (RIM) systems from on-premises to Azure cloud, improving scalability, and operational efficiency.

✍️𝐁𝐮𝐝𝐠𝐞𝐭 & 𝐅𝐢𝐧𝐚𝐧𝐜𝐢𝐚𝐥 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭: Resolved 3-year financial discrepancies across 40 studies, executing $2.5M in change orders.

📈 𝐃𝐞𝐥𝐢𝐯𝐞𝐫𝐲 𝐄𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲 & 𝐒𝐩𝐞𝐞𝐝 𝐭𝐨 𝐌𝐚𝐫𝐤𝐞𝐭: Increased eCOA library reuse from 10% to 50% within six months, driving 10–30% reductions in study build timelines.

🏆 𝐋𝐞𝐚𝐝𝐞𝐫𝐬𝐡𝐢𝐩 𝐑𝐞𝐜𝐨𝐠𝐧𝐢𝐭𝐢𝐨𝐧: Won "The People Leader" award at Signant Health for exceptional team management

🌱 𝐓𝐚𝐥𝐞𝐧𝐭 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭: Created a new middle-management lead role, enabling career growth for software engineers and accelerating onboarding.

Experience

Work history, roles, and key accomplishments

Current

Clinical Systems Consultant

Current

Independent Consultant

Jan 2024 - Present (2 years 5 months)

Advised CROs and software providers on implementation approaches for RIM, EDC, eCOA, and inspection readiness/quality management systems to improve operational readiness and delivery consistency. Supported healthcare services leadership with commercial agreement structure and operational readiness planning for a telepsychiatry engagement.

RIMS EDC ECOA Quality Management Systems GxP Compliance Commercial Structuring Stakeholder Management

Associate Director, Program Mgmt

Calyx

Jan 2022 - Jan 2024 (2 years)

Led globally distributed delivery of regulatory-compliant RIM and EDC implementations for 100+ active clinical studies across Phase I–IV, supporting top pharmaceutical sponsors. Drove $3M cost savings through study decommissioning, platform consolidation, and Azure cloud migration of 80+ studies, achieving zero data loss and 100% audit compliance for 100+ TB of document migrations.

EDC Implementation Azure Migrate Regulatory Compliance Study Decommissioning Audit & Compliance

Clinical Technology Delivery Manager

Signant Health

Jan 2021 - Jan 2022 (1 year)

Directed a $20M eCOA/ePRO clinical technology portfolio, leading a global team of 40+ across 60+ concurrent Phase II–IV studies. Reduced costs by 30%, accelerated timelines by 60%, increased platform library reuse from 10% to 50%, and earned a 'The People Leader' award for exceptional team management.

ECOA EPRO Portfolio Management Team Leadership Timeline Acceleration

eClinical Services Manager

Signant Health

Jan 2019 - Jan 2021 (2 years)

Managed 20 software developers delivering eCOA studies for global pharmaceutical trials and led clinical technology operations for the first FDA-approved COVID-19 vaccine eCOA platform implementation. Delivered for a 45,000-participant study in 6 weeks (50% faster than standard), automated KPI dashboards saving 6 hours per month per manager, and created a lead position program enabling advancement

ECOA FDA Approved Implementation Team Management KPI Dashboard Automation Study Delivery Career Development Operational Excellence

Clinical Systems Project Manager

Signant Health

Jan 2017 - Jan 2019 (2 years)

Managed ePRO and eCOA study implementations with cross-functional teams of business analysts, developers, and test engineers. Reduced support queue turnaround times by 25% through automated dashboard implementation.

EPRO ECOA Project Management Test Engineering Dashboards Support Operations Process Improvement

Healthcare Technology VP

Conexia

Jan 2015 - Jan 2017 (2 years)

Directed a 50-person healthcare technology operations organization spanning software engineering, quality assurance, and customer success for a SaaS platform serving 30+ hospital systems. Improved patient experience and operations by reducing staff costs 15%, lowering abandon call rate 20%, improving first contact resolution 35%, expanding integrations from 2 to 30 providers, and increasing transa

Healthcare Technology Operations SaaS Integration Quality Assurance & Customer Success Cost Optimization

Associate Vice President

Tryal Clinical

Jan 2025 - Present (1 year 5 months)

Directed strategic vendor partnerships and collaborated with sales/product teams to tailor AI-driven eClinical solutions, enabling seamless implementation with rapid study protocol processing. Built KPI tracking for study startup, protocol amendments, and vendor SLA compliance; achieved 90% customer satisfaction and reduced escalations by 30%.

Clinical Operations Vendor Partnership Management EClinical Technology Implementation KPIs Protocol Amendments Audit Readiness