Hannah Yuan

About Hannah Yuan

I specialize in Non-EDC External Data Management, with 18+ years of experience spanning strategic planning, hands-on execution, team building, and oversight of both in-house and CRO operations. My expertise covers eCOA, IRT, cardio safety, imaging, safety labs, PK/PD, clinical biomarkers, Protocol Deviations - ensuring data is fit for purpose, regulatory-ready, and aligned with clinical and scientific goals.I also bring deep experience in EDC systems such as Medidata Rave, Veeva EDC, and BioClinica Express, supporting end-to-end clinical data acquisition, validation, and submission readiness.Throughout my career, I’ve built and led high-performing teams, developed scalable governance frameworks, and implemented innovative workflows across biotech and pharma organizations. My leadership has driven successful data strategies and process optimization at Crinetics, Moderna, Ascendis, AbbVie, and LabCorp, supporting global clinical portfolios and regulatory submissions.At Crinetics, I lead the strategic development of Non-EDC External Data Management frameworks and eCOA systems within Biometrics. I oversee vendor system implementation, data transfer agreements, and quality checks to ensure regulatory readiness and statistical integrity. I also drive cross-functional alignment across CDM, Biostatistics, Statistical Programming, Clinical Ops, Clinical Research, BioAnalysis, and QA to support comprehensive Non-EDC data workflows.I’m passionate about bridging science and operations, embedding quality by design into data workflows, and leveraging AI tools to enhance productivity and collaboration. With certifications in CCDM, PMP, and MLS-ASCP, I bring a unique blend of technical rigor, operational expertise, and strategic vision. Recently certified as a Six Sigma Green Belt, I’ve strengthened my ability to optimize processes and deliver continuous improvement across complex systems.🧭 Strategic & LeadershipData Strategy | Project Management | Process Optimization | Vendor Oversight | Risk Mitigation | Team Building | Collaboration🧪 Technical & DataExternal Data Acquisition & Integration | Data Flow Optimization | Regulatory Compliance (GxP, FDA, ICH, CDISC, SDTM, CDASH)| DTAs | QbD | Sample & Lab Data | EDC Systems🧬 Therapeutic AreasRare Disease | Oncology | Endocrinology | Immuno-Oncology | Infectious Disease | Cardiovascular Lab TechniquesLC-MS | ELISA | PCR | DNA Sequencing | Western Blot | DNA Recombination | RNA Transcription | Cell Culture | Gene Transfection | Primary Tissue Culture

Experience

1. Senior Director, Data Strategy, Process Optimization and Clinical Data Management

   Crinetics Pharmaceuticals

   Mar 2025 — Present · Boston, MA, US

   Assess, design and execute the CDSO operating model, aligning data owners, providers, and stakeholders to deliver high quality, fit for purpose clinical data across all therapeutic areas, including oncology. • Deliver inspection ready non-EDC data management framework, harmonizing diverse data types (eCOA, ECG, labs, imaging, IRT, protocol deviations) and aligning with regulatory expectations for submission readiness. • Optimize external data reconciliation workflows, piloted successfully on pivotal late phase studies, now being formalized for portfolio wide scale up. • Standardize external data formats across eCOA, ECG, labs, imaging, and IRT, securing cross functional buy in and preparing for enterprise rollout. • Participate in EDC Global Library standardization, contributing to harmonized case report form (CRF) libraries and metadata structures to ensure consistency across studies and vendors. • Deployed enterprise sFTP platform, replacing fragmented vendor transfer methods with centralized, secure infrastructure, improving compliance, traceability, and automation. • Lead full in house deployment of eCOA system for pivotal trials, strengthening digital data capture capabilities and reducing reliance on CROs.

Education

• University of California, Berkeley Extension

  Professional Certificate , Project Management

  2019 — 2020

• Tennessee State University

  Master's degree, Cellular and Molecular Biology

  2004 — 2006

• Vanderbilt University

  Professional Certificate of Allied Health Program, Clinical Laboratory Science/Medical Technology

  2006 — 2007

• UC San Diego Extended Studies

  Professional Certificate Program, Clinical Trials Design and Management