Monali Dashapute
Senior Clinical Data Manager at Ocugen | Edison, New Jersey, United States
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Monali Dashapute currently serves as a Senior Clinical Data Manager at Ocugen, where she plays a pivotal role in advancing the company's clinical development programs. In her capacity as Clinical Data Lead, Monali oversees the end-to-end management of clinical trial data, ensuring compliance with regulatory standards such as CFR 21 Part 11 guidelines and industry best practices. Her responsibilities include coordinating with Contract Research Organizations (CROs) to facilitate high-quality data collection, validation, and reconciliation processes, thereby maintaining the integrity and accuracy of clinical datasets. Monali’s expertise in implementing strategies outlined in the Data Handling Plan (DHP) and adhering to Standard Operating Procedures (SOPs) ensures that data management activities align seamlessly with project timelines and regulatory expectations.
At Ocugen, Monali leverages her extensive knowledge of CDISC standards, MedDRA coding, and WHO Drug terminologies to streamline data workflows and facilitate efficient data analysis. Her proficiency with electronic CRFs (eCRFs), Case Report Forms (CRFs), and data reconciliation tools enhances the robustness of clinical datasets across diverse therapeutic areas, including ophthalmology and antiviral therapies. Monali’s experience with Serious Adverse Event (SAE) reporting and data management for complex clinical trials ensures patient safety and regulatory compliance. Her leadership in vendor management and her ability to coordinate cross-functional teams contribute significantly to the successful delivery of clinical data milestones. Through her strategic oversight and technical expertise, Monali Dashapute continues to drive high standards of data quality and integrity, supporting Ocugen’s mission to develop innovative therapies and bring impactful solutions to patients worldwide.
Senior Clinical Data Manager at Ocugen in August 2022 to Present
Clinical Data Manager at eClinical Solutions in October 2019 to August 2022
Associate Clinical Data Manager at UBC in June 2018 to October 2019
Office Coordinator at Dr. Ragin Patel LLC NJ in March 2017 to May 2018
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North Maharashtra University, Bachelor of Science - BS
Suryadatta Institute of Management and Mass Communication, Master's degree
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oracle siebel clinical
Clinical Trial Management System (CTMS)
CDISC, MedDRA, WHO Drug
CFR 21 Part 11 guidelines
Clinical Data Management, CRO Management
Medidata Rave
Oracle Clinical
Edit Check Specifications (ECS)
Data Transfer Agreements (DTAs)
Data Management Plan (DMP)
Serious Adverse Event (SAE)
Clinical Data
Clinical Data Management
FDA regulations
Data Transfer Agreement (DTA)
Database Lock (DBL)
Contract Research Organization (CRO)
Vendor Management/Vendor Oversight
Data Quality
Clinical Data Management
Clinical Trial
Data Cleaning
Query Management
Microsoft Office Applications, specifically MS Project and MS Excel
Team Collaboration
Cross-functional Coordination
Mock CRF
Team Leadership and Monitorship
Electronic Medical Record (EMR)
Data Entry
Data Validation
System Testing (UAT)
data reconciliations
Data Accuracy & Reporting
Electronic Data Capture (EDC)
Clinical Research Management Systems
Clinical Research
Clinical Study Management
CDISC (SDTM) Standards
Standard Operating Procedures (SOPs)
Electronic CRF (eCRF)
Case Report Form (CRFs)
Trial Management
CDISC Standards
Risk Management
Veeva Vault
Development Strategy
Regulatory Guidelines
Adverse Event Reporting
Data Validation
CDM Regulations
Vendor Management
Communication
Medidata rave
Cross-functional Team Leadership
Data management plan
Written Communication
Data Management
Study Data Tabulation Model (SDTM)
Clinical Development
CDM
Microsoft Excel
Biometrics
Standard Operating Procedure (SOP)
Protocol Review
Project Management
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Discover more about OcugenWhat is Monali Dashapute email address?
Email Monali Dashapute at [email protected]. This email is the most updated Monali Dashapute's email found in 2026.
How to contact Monali Dashapute?
To contact Monali Dashapute send an email to [email protected]. (updated on April 29, 2025)
What company does Monali Dashapute work for?
Monali Dashapute works for Ocugen
What is Monali Dashapute's role at Ocugen?
Monali Dashapute is Senior Clinical Data Manager
What is Monali Dashapute's Phone Number?
Monali Dashapute's phone (201) ***-*246
What industry does Monali Dashapute work in?
Monali Dashapute works in the Research industry.
Monali Dashapute Email Addresses
Monali Dashapute Phone Numbers
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