Monali Dashapute
Senior Clinical Data Manager || CDM Strategy || EDC Systems || Regulatory Compliance || Open to Opportunities in Clinical Data Management ||
- Role
- Senior Clinical Data Manager at Ocugen
- Location
- Edison, NJ, US
- LinkedIn followers
- 500 followers
About Monali Dashapute
Professional Summary: Senior Clinical Data Manager with 6+ years of experience…
Experience
Senior Clinical Data Manager
Aug 2022 — Present · PA, US
Spearheaded comprehensive data management activities for clinical trials in ophthalmology, immunology, and orthopedics, delivering high-quality, submission-ready datasets in compliance with protocol and regulatory standards.• Led ophthalmology study builds in Medidata Rave, Inform managing complex endpoints such as visual acuity, OCT, and retinal imaging, and ensuring accurate reconciliation of ocular adverse events with safety databases.• Oversaw immunology trials involving biologics and immune response markers, with a focus on precise biomarker integration and cross-platform data reconciliation between laboratory vendors and EDC systems.• Directed data management for orthopedic device and surgical studies, ensuring accurate capture of implant data, surgical outcomes, and post-operative assessments in alignment with Class medical device regulations.• Authored and maintained essential study documentation, including Data Management Plans (DMPs), CRF Completion Guidelines (CCGs), Edit Check Specifications (ECS), and Data Transfer Agreements (DTAs).• Designed and executed tailored edit checks and data review strategies aligned with therapeutic area-specific endpoints and protocol-defined assessments.• Conducted thorough User Acceptance Testing (UAT), including Edit Check and Screen UAT, across multiple platforms to validate database configurations prior to go-live.• Managed third-party data integrations (e.g, ePRO, eCOA, IRT, labs, imaging, safety), ensuring seamless mapping, validation, and reconciliation into clinical databases.• Collaborated closely with cross-functional teams—including clinical operations, biostatistics, and pharmacovigilance—to provide real-time data oversight and expedite issue resolution.• Performed ongoing data reviews, SAE reconciliation, and medical coding using MedDRA and WHO-DD, applying therapeutic context to ensure appropriate classification and consistency.
Education
Suryadatta Institute of Management and Mass Communication
Master's degree
North Maharashtra University
Bachelor of Science - BS
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