Janina R.

Experience

1. Senior Clinical Trial Manager

   Biomea Fusion

   Apr 2024 — Present · Redwood City, CA, US

   Execute sponsor monitoring oversight visits to assigned CRO CRAs and clinical research sites to ensure clinical trial progress aligns with protocols, regulatory standards, and company requirements.• Drive timely completion, budget compliance, and adherence to SOPs, FDA/EMA regulations, and ICH/GCP guidelines.• Oversee execution of tasks outlined in study management plans to ensure alignment with study objectives and operational protocols.• Mitigate risks to clinical trial conduct and data integrity by partnering with project teams, sites, and Study Leads.• Craft study-specific tools and templates to streamline processes, enhance efficiency, and maintain data quality standards.• Enforce inspection readiness for assigned studies to verify completeness and accuracy of Trial Master Files (TMF/eTMF) and Investigator Site Files (ISF).• Investigate issues at investigational sites or with vendors and implement targeted action plans to rectify concerns.• Conduct thorough site and CRA assessments at high-enrolling and high-risk sites for Phase I/II metabolic disease studies.• Support site and sponsor teams during FDA inspections to ensure compliance and successful outcomes.• Deliver comprehensive CRA training sessions to elevate performance and protocol adherence.• Supported 50+ sites in early-phase diabetes trials, conducting monitoring visits and ensuring compliance with ICH-GCP and protocol standards.• Developed and presented site-specific training materials, improving site staff protocol understanding and reducing protocol deviations.

Education

• San Francisco State University

  Clinical Trials Design & Management

  2008 — 2009

• University of California, Berkeley

  Bachelor of Arts, ENGLISH LANGUAGE AND LITERATURE/LETTERS