Pooja N.
Clinical Data Manager/ Programmer @ Bausch + Lomb | Data Management
- Role
- Clinical Data Manager Programmer at Bausch + Lomb
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Pooja N.
With a Master\'s in Public Health from Emory University and a Bachelor\'s in Pharmacy, I…
Experience
Clinical Data Manager Programmer
Mar 2023 — Present · Bridgewater, NJ, US
Leads Data Management activities for multiple trials, providing high-level expertise to support clinical studies and ensuring compliance with regulatory and industry standards.• Provides comprehensive oversight of CRO Data Management activities, ensuring consistency, compliance, and alignment with program-level standards; tracks milestones and deliverables, escalates issues, and ensures resolution.• Outlines the Data Management, Review and Cleaning Plan and develops strategy for data cleaning to ensure smooth and consistent data review process. • Creates Data Validation Plan (DVS), Edit Check Specifications (ECS), CRF Completion Guidelines (CCGs) and provides Data Management insight to maximize the data validation strategy.• Leads the integration of clinical data from third-party system into the EDC system, enhancing data accuracy and avoiding manual entry errors.• Develops and implements SAS-based automation tools for data quality checks, such as Programmed Edit Checks, Listings and Data Refining programs, significantly reducing the data review timelines.• Develops Clean Patient Tracker, Page Status and Query Status Reports to monitor data cleaning for the trial using SAS 9.4 or R.• Supervises SAE/AE reconciliation, MedDRA/WHO-DD coding prior to Interim data analysis and/or database lock.• Drives and supports vendor qualification for data management; defines/specifies scope of work for functional tasks.• Drives the transfer, locking, and archiving of study databases and ensures timely delivery of US FDA deliverables in accordance with company SOPs and ICH/GCP.• Prepares recommendations for new or improved processes for data management and data flow.• Participates in key Data Management documentation and ensures inspection readiness; ensures documentation is aligned with best practices and provides improvement recommendations based on DM expertise.
Education
Campbellsville University
Master of Leadership and Management
2023 — 2025
Institute Of Chemical Technology
Bachelor's degree
2015 — 2019
Emory University
Master's degree
2019 — 2021
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