Pavani Chitkela
Arizona,USA
Summary
Accomplished Clinical Data Management professional with over 5 years of progressive experience in clinical data review, data analytics, and quality oversight across diverse therapeutic areas. Expertise in ICH-GCP, FDA regulations, and client SOP compliance drives a proven track record of enhancing data accuracy, implementing process improvements, and conducting thorough scientific data reviews. A collaborative approach with Study Responsible Physicians (SRP) and Study Responsible Scientists (SRS) ensures the integrity and readiness of high-quality data for regulatory submission. Recognized for strong leadership skills, meticulous attention to detail, and proactive communication within cross-functional teams.
Overview
7
7
years of professional experience
Work History
Senior Clinical Data Manager
IQVIA
05.2024 - 12.2024
- Performed scientific clinical data review and complex data analytics for high-complexity trials in collaboration with SRP and SRS.
- Conducted on-site and remote monitoring visits for Phase I–IV clinical trials in compliance with ICH-GCP, FDA, and IQVIA SOPs, ensuring subject safety and data accuracy.
- Reviewed study protocols, informed consent forms, and case report forms (CRFs) to verify protocol adherence and data integrity within EDC systems.
- Managed all aspects of assigned sites, including qualification, initiation, routine monitoring, and close-out visits, ensuring timely issue resolution and study compliance.
- Developed and utilized monitoring tools, templates, and checklists aligned with IQVIA quality standards to improve oversight consistency and efficiency.
- Prepared detailed monitoring reports, follow-up letters, and CAPA plans within CTMS and eTMF systems, ensuring full documentation of study activities.
- Collaborated with cross-functional teams—including data management, regulatory affairs, and project management—to support seamless trial execution.
- Ensured audit and inspection readiness by maintaining complete, compliant, and inspection-ready Trial Master File (TMF) documentation.
- Supported risk-based monitoring (RBM) initiatives, process improvements, and investigator/site training to enhance monitoring quality and operational performance.
- Developed and maintained Integrated Review Plans and ensured data accuracy, clarity, and regulatory compliance.
- Reviewed Data Management Plans (DMP), Data Transfer Agreements (DTA), and Data Validation Documents for multiple trials.
- Led meetings with SRP/SRS, ensuring alignment on data review strategy, metrics, and deliverables.
- Supported inspection readiness by maintaining audit-ready documentation and ensuring adherence to GCP and SOPs.
- Led and mentored junior data managers; coordinated deliverables to ensure quality and timeliness.
- Worked with EDC programmers for eCRF design, edit checks, UAT testing, and database build oversight.
- Communicated updates to senior stakeholders and facilitated cross-functional team collaboration.
- JNJ
Clinical Data Specialist
Syneos Health
05.2021 - 06.2022
- Participated in database design, setup, and validation for clinical trials, ensuring accuracy and compliance.
- Generated and resolved data queries; collaborated with CRAs and study sites to maintain data integrity.
- Conducted central lab, ECG, and SAE reconciliations and supported data quality from study start to database lock.
- Authored and maintained DMPs, CRF completion guidelines, and annotated CRFs.
- Provided data review listings, ad hoc reports, and metrics to track study progress using BO4 tools.
- Led client meetings, documented minutes, and ensured deliverables were met per timelines.
- Pfizer
Clinical Data Specialist
IQVIA
11.2020 - 05.2021
- Created and reviewed DMPs, Edit Check Documents, and data validation plans to ensure protocol compliance.
- Collaborated with auditors and sponsors to ensure data integrity and study adherence to ICH-GCP standards.
- Managed discrepancy management, database lock, and data reconciliation activities for oncology trials.
- Developed eCRFs and database edit check specifications per CDASH and client SOPs.
- Provided oversight to internal and external teams for ongoing clinical data review and issue resolution.
- JNJ
Clinical Data Analyst I / II
Covance (Fortrea)
10.2018 - 11.2020
- Developed Data Management Plans and managed end-to-end clinical data management lifecycle.
- Performed discrepancy management and edit check validation for multiple protocols.
- Executed data validation, query generation, and tracking of study progress and deliverables.
- Reviewed and maintained Trial Master File (TMF) for accuracy and compliance.
- Collaborated with cross-functional teams to ensure clean, inspection-ready data.
- Daiichi
Project Manager
Value Point Knowledge Works
01.2018 - 10.2018
- Coordinated clinical project activities, trained staff, and managed client communication.
- Established auditing and quality procedures ensuring clean, consistent trial data.
- Oversaw project timelines, deliverables, and vendor management for clinical projects.
Education
Master’s - Biotechnology
IADC Indian Academy Group of Institutions
Bangalore, IndiaBachelor’s - Biotechnology, Biochemistry, and Chemistry
Aurora Degree and PG College
Hyderabad, IndiaSkills
- Scientific clinical data review
- Clinical Data Management Planning
- Knowledge of ICH-GCP
- Knowledge of FDA regulations
- Cross-functional collaboration
- Experience in Oncology
- Experience in Hematology
- Experience in Cardiology
- Experience in Immunology
- Experience in Vaccines
- Database systems: Medidata RAVE
- Database systems: Oracle Clinical
- Database systems: InForm
- Database systems: Veeva Vault
- Data analytics tools: J-Review
- Data analytics tools: Spotfire
- Data analytics tools: Excel dashboards
- Data analytics tools: SAS
- Data analytics tools: SQL
- Data quality management
- Discrepancy management
- SAE reconciliation
- Leadership
- Mentoring
- Inspection readiness support
- Proficient in CDISC
- Proficient in CDASH
- Proficient in 21 CFR Part 11 compliance
- Clinical data management
- ICH-GCP compliance
- Risk-based monitoring (RBM)
Timeline
Senior Clinical Data Manager
IQVIA
05.2024 - 12.2024
Clinical Data Specialist
Syneos Health
05.2021 - 06.2022
Clinical Data Specialist
IQVIA
11.2020 - 05.2021
Clinical Data Analyst I / II
Covance (Fortrea)
10.2018 - 11.2020
Project Manager
Value Point Knowledge Works
01.2018 - 10.2018
Bachelor’s - Biotechnology, Biochemistry, and Chemistry
Aurora Degree and PG College
Master’s - Biotechnology
IADC Indian Academy Group of Institutions