Manichcha Sarang
@manichchasarang
Clinical Data Manager with 5 years' experience in CDM, EDC systems, and regulatory documentation.
IndiaWhat I'm looking for
I am a Project Data Manager with five years of experience in Clinical Data Management and Regulatory Affairs, skilled in discrepancy management, vendor reconciliation, and eTMF/documentation processes. I have hands-on experience with EDC platforms, post-production migration tasks, and edit-check/UAT activities.
I have led teams and coordinated client interactions while maintaining study health through real-time data cleaning, monthly study health meetings, and timely close-out activities. I created and maintained DMPs, eCRF completion guidelines, and performed Pinnacle21 reviews and SAE reconciliations.
I hold a Bachelors in Biotechnology from Mumbai University and a Postgraduate Diploma in Clinical Research and Management from ClinoVision. I bring strong analytical ability, proactive learning, and clear communication to deliver data quality and regulatory-compliant study deliverables.
Experience
Work history, roles, and key accomplishments
Project Data Manager
Access Healthcare Pvt. Ltd
Dec 2021 - Sep 2024 (2 years 9 months)
Manage clinical data activities across conduct and close-out phases, driving real-time data cleaning and discrepancy resolution while leading study health meetings and coordinating vendor reconciliations to ensure timely database readiness.
Clinical Research Coordinator
Vasta Bioinformatics
Mar 2020 - Apr 2021 (1 year 1 month)
Supported clinical operations with data-related tasks during study conduct including real-time cleaning, eTMF maintenance, and coordination with study teams to track patient data and study status.
Project Data Manager
Vasta Bioinformatics
Jan 2019 - Mar 2020 (1 year 2 months)
Performed data cleaning, discrepancy management, and post-production change activities including UAT and migration; maintained DMPs, eCRF completion guidelines, and executed vendor reconciliations for multiple data types.
Performed junior-level data analysis tasks supporting clinical data workflows, contributed to data reconciliation and reported quality issues to improve dataset readiness.
Education
Degrees, certifications, and relevant coursework
ClinoVision - Institute for Clinical Research
Postgraduate Diploma, Clinical Research and Management
2018 - 2019
Completed a Postgraduate Diploma in Clinical Research and Management (trained and certified) between August 2018 and December 2019.
University of Mumbai
Bachelor of Science, Biotechnology
Completed a Bachelor in Biotechnology from the University of Mumbai, graduating in June 2018.
Availability
Location
IndiaAuthorized to work in
Job categories
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