Alyssa Johncola
Clinical Project Manager & Research Coordinator - Using Advanced Research Techniques for Optimal Patient Outcomes & Study Execution | Designing Studies, Developing Protocols, & Optimizing Lab Workflows
- Role
- Clinical Operations Lead Account Director Clinical Project Management at Regenmed Circles
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Alyssa Johncola
I am a clinical operations leader dedicated to advancing medical innovation through…
Experience
Clinical Operations Lead Account Director Clinical Project Management
Sep 2024 — Present
In this dynamic leadership role, I drive critical initiatives across clinical operations, project management, and business development within a cutting-edge Real World Evidence (RWE) start-up. I have been instrumental in establishing and scaling patient-centric trial methodologies, and managing a diverse portfolio of over 90 international clients. My strategies are optimized through the effective use of CRM tools (HubSpot) and data analysis. I leverage platforms like JIRA, Confluence, and Canva for efficient operations and content creation. •Led global clinical operations and strategy for an RWE EDC company, ensuring patient-centric and pragmatic trials adhered to FDA 21 CFR Part 11 compliance, utilizing JIRA and Confluence for project tracking.• Managed key client relationships across North America and EMEA, including sponsors, CROs, biotech companies, medical device manufacturers, medical advocacy groups, and clinicians across diverse therapeutic areas.• Developed and scaled clinical research protocols, SOPs, and IRB submissions, implementing strategic data collection plans to meet client needs and ensure regulatory compliance, with an emphasis on data analysis for insights and improvements.• Spearheaded new client acquisition and onboarding, actively managing and segmenting client portfolios to drive growth and deliver exceptional client-focused services, informed by data analysis of client trends and needs.• Oversaw the hiring, training, and daily operations for a global team of direct reports, aligning team performance with overarching business objectives. • Facilitated critical enhancements to the EDC platform, optimizing efficiency and compliance through improved protocol-building tools and standardized materials.• Used data analytics knowledge to appeal to investors and supported clients in developing publishable content, conference materials, and FDA submissions, leveraging Canva for professional visual aids and presentations.
Education
University of Pennsylvania
Bachelor of Arts - BA, Italian Culture and Language, Pre-medicine
2011 — 2015
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