Data Management Clinical

MADHURI POGULA

Halethorpe, MD www.linkedin.com/in/madhuripogula 302-***-**** ***************@*****.*** Summary:

· 6+ years of expertise in Senior Clinical Data Management for Phase I, II, and III studies, focusing on data analysis.

· Knowledge of ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries

· Well-versed in study start-up, conduct, and Close-out activity for Oncology, Ophthalmology, and Early development therapeutic areas.

Skills:

Technical skills: Medidata Rave EDC, REDCap, SQL, R, AWS, SQL, Unix, Linux, Word, Microsoft Office Suite

(Excel, Word, PowerPoint, Access), J review, ICH-GCP guidelines, SDTM, Medical Coding, Veeva Vault eTMF, CDMS Database management system, Pharmaceutical, Biotechnology. Soft Skills: Project management, Leadership, Risk Management, Team Collaboration, Effective Communication, Flexibility to change, Effective time management, Problem Solving. Relevant experience:

Data Analyst MSN Pharmaceuticals (Piscataway, NJ) SEP 2024-Present Skill set: Clinical and commercial data analysis, third-party data acquisition, vendor coordination, pharmaceutical manufacturing analytics, Data Transfer Agreements (DTAs), KPI dashboard development, statistical analysis using SAS/Python, data cleaning and transformation, Data Management Plans (DMPs), regulatory documentation, audit readiness.

· Supported the acquisition and validation of external data from third-party vendors such as laboratories and eCOA providers for use in clinical reporting and manufacturing analysis.

· Assisted in drafting and reviewing Data Transfer Agreements (DTAs) to ensure alignment with organizational standards and regulatory expectations.

· Coordinated with internal data management and engineering teams to support the integration of third- party data into internal systems.

· Helped maintain study-related documentation including data flow diagrams, external data logs, and DTA records for audit and inspection readiness.

· Communicated regularly with external vendors to track deliverables, resolve data discrepancies, and ensure timely data submissions.

· Used SAS and Python to clean, merge, and validate incoming datasets, reducing manual review effort and improving data quality.

· Built Power BI dashboards to track vendor performance and key data acquisition metrics.

· Contributed to the preparation of data review and management plans, incorporating third-party data handling procedures.

Sr. Clinical Data Manager TECHSOL LIFE SCIENCES (India) JUN 2020- JAN 2023 Skill set: Oncology Studies, Database design, CRF design, development of edit checks and validation checks, eCRF Completion guidelines (CCGs), Data Transfer Specification (DTS), Data Management Plans (DMPs), Data quality management plans (DQMP), Data review plans, Test script preparation, User acceptance testing (UAT), Migration, database snapshot, medical coding, and documentation.

· Led the validation of clinical trial databases, software, and automated systems, ensuring compliance with FDA regulations and GAMP 5 principles.

· Orchestrated study start-up for 8 oncology trials, including database design and development of 50+ case report forms (CRFs), enhancing operational efficiency by 20%.

· Conducted user acceptance testing (UAT) for 12 clinical trial databases and 500+ edit checks, achieving a 98% first-time pass rate for oncology therapeutic studies.

· Collaborated with 6 cross-functional teams, reducing interdepartmental communication delays by 25% and ensuring timely data delivery for 15+ projects.

· Collaborated with external vendors to manage and monitor the acquisition of clinical trial data, ensuring data transfers were timely and met protocol requirements.

· Participated in the creation and review of Data Transfer Specifications (DTS) and Data Transfer Agreements (DTAs) to align external data deliveries with internal standards.

· Provided oversight to 4 third-party vendors, ensuring 99% accuracy in data transfers involving over 1 million data points annually.

· Managed 5000+ queries and performed medical coding for 20,000+ adverse events, resolving 95% of discrepancies within 48 hours.

· Supported the preparation of 30+ IRB and FDA submissions, leading to a 100% approval rate for oncology trials and reducing submission time by 20%.

· Created and maintained project schedules for 15 clinical trials, delivering complete and reliable data 10% faster than the industry average while adhering to 100% of standard operating procedures

(SOPs).

· Led preparations for 10 database locks, ensuring 99.9% data cleanliness and verification, reducing time to final analysis by 25%, while maintaining full regulatory compliance.

· Maintained up-to-date clinical data management documentation for 20+ studies, ensuring 100% readiness for audits, inspections & regulatory submissions in compliance with 21 CFR Part 11.

· Mentored 5 junior colleagues, resulting in a 30% increase in team productivity. Clinical Data Manager TECHSOL LIFE SCIENCES (India) JUN 2019- JUN 2020 Skill set: Data validation checks, Data listing, SAE reconciliation, query management, Third-party data reconciliation, Database freezing, locking & Archiving, Data correction Requests/Forms (DCRs, DCFs)

· Ensured 99.5% clinical trial database accuracy by managing 10,000+ queries, reviewing 500+ edit checks, and reconciling data from 5 third-party sources (ePRO, Lab, IRT, Imaging, PK/PD), leading to a 20% reduction in query resolution time.

· Developed, validated, and maintained 8 data management tools and systems, enhancing data collection efficiency by 35% and minimizing processing errors by 25%.

· Executed User Acceptance Testing for 15 clinical databases, reviewing 1000+ data validation specifications and resolving 98% of data discrepancies within 48 hours.

· Developed and executed validation protocols (IQ/OQ/PQ) for clinical trial systems, including Laboratory Information Management Systems (LIMS) and Data Integrity systems.

· Ensured adherence to FDA 21 CFR Part 11 by developing compliant CSV documentation and supporting system audits.

· Coordinated with vendors during study conduct to resolve issues related to delayed or incomplete data transfers.

· Reviewed third-party data mapping and assisted in aligning it with CDISC-compliant structures for clinical database integration.

· Assisted in drafting functional specifications for external data validation and provided feedback to ensure DTA compliance.

· Managed reconciliation of third-party data sources with EDC, resolving discrepancies in lab, IRT, and PK/PD datasets in collaboration with internal teams.

· Gained hands-on experience with AWS and other cloud-based development tools to manage and analyze large datasets.

· Implemented various EDC solutions, including REDCap and Medidata Rave, for efficient data capture and management in clinical trials.

Clinical Research Coordinator KAMINENI LIFE SCIENCES DEC 2017 – APR 2019 Skill set: Data collection, Data cleaning, Data reconciliation, Data delivery, RECIST, data listing, SAS checks.

· Decreased data discrepancies by 30% through rigorous quality control processes

· Reduced RECIST data review time by 40% by implementing streamlined workflows

· Improved efficiency of data listings generation by 20% using J-Review & EDC systems

· Assisted in clinical trial database locking process, reducing closure time by 15% for 8 studies.

· Compiled and presented 36 insightful project status reports to facilitate informed decision-making. Additional experience:

Clinical Pharmacist Intern AIG HOSPITALS SEP 2015 – DEC 2016

· Improved student performance by 25% through clear and constructive feedback

· Reduced grading turnaround time by 30% while maintaining 99% accuracy

· Implemented a new system for student record data entry, increasing efficiency by 40%

· Assisted in developing 5 educational materials that enhanced student learning outcomes by 15%. Education:

· MS in Health Information Technology MAY 2024 University of Maryland-Baltimore County, USA.

· Bachelor in Doctor of Pharmacy JUL 2021 KVK College of Pharmacy, JNTUH, India.

· Good Clinical Practice (GCP) Certification- SEP 2024, ICH-GCP guidelines and local regulations

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