Megan Shelby
Clinical Operations & Strategy Consultant | Founder, Axia Clinical Solutions LLC | Oncology & Rare Disease | Study Management | HCP Engagement
- Role
- Senior Manager Field Operations and Medical Education at Cellectar Biosciences, Inc
- Location
- Grand Rapids, MI, US
- LinkedIn followers
- 500 followers
About Megan Shelby
With over a decade of combined clinical and biopharma experience, I specialize in…
Experience
Senior Manager Field Operations and Medical Education
Sep 2023 — Present
Strategic Stakeholder Engagement: Cultivated and maintained key relationships with clinical site investigators, key opinion leaders (KOLs), and scientific community driving engagement and enhancing clinical trial execution. Increased corporate and study awareness at key oncology conferences and advocacy events, driving disease-state awareness and fostering partnerships within the scientific community.Clinical Oversight and Support: Provided scientific and operational oversight, including study implementation, patient recruitment, and monitoring data metrics to ensure alignment with timelines and successful database lock.Scientific Expertise: Served as a scientific resource for internal and external stakeholders, delivering medical education, disease-state insights, and study-specific training. Cross-Functional Collaboration: Collaborated with cross-functional teams on critical initiatives, including market research, product education, protocol development, and pre-launch activities to support strategic goals and ensure alignment across clinical operations. Regulatory and Compliance Contributions: Assisted in NDA preparation, quarterly coding quality control (QC), and Sponsor assessment for serious adverse events (SAEs), ensuring adherence to regulatory and ethical standards.Corporate Social Media Outreach: Spearheaded a strategic social media outreach campaign to drive traffic to corporate and study-specific websites, resulting in significant engagement and measurable successOperational Excellence: Led weekly clinical operations meetings, contributed to mock audit planning and execution, and proactively identified and mitigated potential issues at the site level to ensure smooth execution of company-sponsored studies. Protocol and Product Development: Contributed protocol development and provided field-related insights to inform market strategies, supporting product launch planning and advancing therapeutic innovation.
Education
Central Michigan University
Bachelor of Science - BS, Neuroscience and Psychology
2007 — 2011
Central Michigan University
Master of Science - MS, Physician Assistant
2011 — 2013
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