Highlights:

Skills:clinical research, clinical data management, electronic data capture, EDC, CRC, Third Party Vendors, CRF, UAT, DMP, DQRP, Reconciliation, leadership, project management, decision making, training

Global Data Manager Specialist 12/2023 - 07/2024
The Janssen Pharmaceutical Companies of Johnson & Johnson, , United States
Industry: Pharmaceutical
• Individual contributor role with decision-making responsibility with minimal direction from manager or lead. • A leadership role with the CRO, the trial customer(s), GDM and other internal and external partners to establish, align, and confirm data management expectations for assigned trial(s)
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Senior Clinical Data Associate 06/2021 - 12/2022
SyneosHealth, , India
Industry: Clinical Research Organization CRO
• Oversight Control: Perform trial-level oversight controls to maintain data quality and accuracy throughout the trial lifecycle • Team development: Contribute to identifying lessons learned, best practices, and FAQs, promoting continuous improvement and knowledge sharing within the team. Develop training plans; perform on job trainings and assessments of newly recruited data managers.
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Associate Data Team Lead 04/2016 - 05/2021
IQVIA, , India
Industry: Clinical Research Organization CRO
• Deliverables Management: Strategically planned and tracked content, format, quality, and timing of data management deliverables, including CRFs, data review plans, QC plans, oversight plans, database release plans, final datasets, submission plans, and archival, delivering all milestones punctually. • EDC Database Lifecycle: Utilized advanced development tools to design databases within EDC platforms (e.g., Medidata Rave, Inform, Oracle Clinical) and oversee the entire study database lifecycle.
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Data Analyst 02/2012 - 03/2016
Cognizant Technology Solutions, , India
Industry: Business Process Outsourcing
• Understand and comply with core operating procedures and working instructions • Experience working as an individual contributor on moderate to complex projects. Ensure deliverables meet quality and are compliant to company policies
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Process Associate 12/2010 - 02/2012
Tata Consultancy Services, , India
Industry: Business Process Outsourcing
• Query data inconsistencies in compliance with standard operating procedures, client guidelines and regulatory agency guidelines. • Perform hands on reconciliation of central lab, pharmacogenetics. Communicate with vendors using vendor issue log.
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University of Mumbai 06/2005 - 04/2008
, , India
Degree: Bachelor's Degree
Major:Biotechnology
Biotchnology

Priyanka Kalpande CDM CDM, EDC