Palak Nigam
Senior Clinical Data Manager @GE HealthCare
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WORK HISTORY
Senior Clinical Data Manager @GE HealthCare
US
As the sole Data Manager for the company, responsible for all aspects of the clinical trial data management processes from study start up to database lock. • Drive end-to end study data quality and integrity by providing oversight of contracted Clinical Research Organizations (CROs) and external vendors• Collaborative member of the study team.• Oncology Test Kit development using AI and machine learning to identify cancer biomarkers in blood samples• Manage all Data Management activities and CRO Oversight for the 0.5 M Injection on QT/QTc study with subjects • Develop and manage Sponsor Data Review Plan for Medical Monitors, Clinical Operations, and Data Management monthly listing reviews as part of vendor oversight• Assist in developing metrics and trackers to determine which subjects deemed eligible for analysis, and cohort building/refinement for validation testing• Completed two recent Mid Study Database Updates as part of a database rescue plan, standardizing and correcting database design flaws to improve data quality and allow for more appropriately standardized development of the SDTM and ADaM files for analyses.
EDUCATION
University of the Cumberlands
Master's degree
St. Joseph's Convent Sen Sec School - India
Biology/Biological Sciences, General
Modern Dental College of Research Center, Gandhi Nagar, Indore
Bachelor's degree
Valparaiso University
Master's degree
ABOUT PALAK NIGAM
Around 7 years of hands on clinical trial and data management experience. Senior Management roles, Clinical Data Management oversight. Serve as the lead program data manager on development projects working in Rave/Veeva/Oracle, collaboration with external vendors with responsibility for managing the design, implementation, and maintenance of electronic case report forms, and electronic edit checks for new and ongoing clinical research studies. Additional responsibilities include the design, development, implementation, and execution of data review plans to ensure the quality of collected clinical data, including oversight of multi-functional data review teams, management of electronic data received from specialty vendors (e.g, clinical laboratory, central image review), and the development of technical study documents and reports such as data transfer plans, annotated case report forms and database/data quality metrics. eTMF file structure development based on the standard DIA eTMF Reference Model guidelines using Veeva Vault and SharePoint file systems. Part of CRO selection team, RFP process, budgeting/bidding DM portions of overall study proposals. I hold a master\'s degree in Project Management from University of the Cumberlands, Masters degree in Healthcare Management from Valparaiso University and a bachelor\'s degree in Dentistry from Modern Dental College of Research Center. I have developed skills in Quality System, Quality Assurance, and Manual Testing, and I stay updated with the latest industry trends, regulatory changes, and technological advancements. I am a results-driven, passionate, and collaborative professional, who thrives on challenges and seeks growth and development in the clinical research field.
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