Clinical Records Associate Specialist with 3+ years supporting global clinical trials in a regulated medical device environment. Skilled in eTMF / Veeva Vault management, CTMS data accuracy, inspection readiness, training documentation oversight, and process improvement — known for translating complex clinical records processes into clear, actionable guidance.
Jawa is a Clinical Records Associate Specialist at Edwards Lifesciences, supporting global clinical trials within THV Global Clinical Records. Since joining in October 2022, she has progressed from Rep to Senior Rep to Associate Specialist — building expertise across eTMF / Veeva Vault management, CTMS data accuracy, inspection readiness, and cross-functional process improvement.
Her academic background is in Business Administration with a concentration in Information Systems & Decision Sciences from California State University, Fullerton, where she developed a foundation in data analysis, statistical modeling, and data-driven decision-making — a lens she brings to clinical operations work today.
EN / AR — BilingualJOURNEY V4.0 Leads Team (THV) — orchestrated a rapid global return to clinic for a valve device, aligning stakeholders across regions to execute one of the most accelerated clinical restart plans in recent memory. Delivered Protocol V4.0 authorship, governance review, and site-facing tools in a fraction of typical timelines, securing regulatory approval across five countries.
FDA BIMO Team — recognized for cross-functional contributions to FDA inspection readiness and eTMF quality.
Strengthened leadership, communication, strategic thinking, and career development planning.
Supported development of Safety TMF reporting tools, enhancing Safety team TMF oversight.
Presented an overview of the study training improvement initiative to the broader Shared Services team.
Identified a gap and developed a best-practice process for training record documentation in line with GDP and compliance.
"Jawa has a wealth of knowledge and excellent presentation skills. She is able to break down complex processes into concise information and would be a great asset to all teams. Her proactive support creates a more streamlined process, and she fosters a collaborative, positive work environment."
Coursework emphasized data analysis, statistical modeling, decision-making, business systems, and analytical tools to support data-driven recommendations.
Open to conversations about clinical operations, TMF management, and process improvement roles.