Ramya Gundapaneni
San Diego
Summary
Over 3 years of experience in Clinical Data Management. Experienced and detail-oriented Clinical Data Management professional with a strong background in ensuring the quality, integrity, and compliance of clinical trial data. Proficient in managing the phase I, II and III Clinical Trial studies including study set-up, conduct, and close-out phases. Experienced in working with multiple EDC databases like Inform-Oracle, Medidata Rave, Medrio, Viedoc, Veeva vault, Assisted in designing and imaging the databases by reviewing the protocol, unique eCRF, edit check specifications, UAT and Go-live activities. Worked on therapeutic areas like Oncology, Immunology, Cardiovascular, Chronic Kidney Diseases, Rare Diseases, Medical Devices, Neurovascular and Vaccines. Familiar with and Knowledge of ICH-GCP, 21 CFR part 11, GCDMP, US FDA safety reporting and guidelines, CDASH and CDISC regulatory guidelines.
Overview
5
5
years of professional experience
Work History
Clinical Data Manager
Insight Clinical
San Marcos, CA
08.2022 - Current
- Performed data management activities starting from study start-up to database lock for various studies
- Developed edit check specifications and ensuring both CRF and edit checks are following industry best practices as well as the study protocol
- Reviewed and performed User Acceptance Testing (UAT) of the database providing the updates and performed testing of the screens via UAT scripts and executing validation procedures
- Reviewed Data Management Plan (DMP) regularly throughout the project and updated to reflect required changes
- Developed Data Transfer Agreements (DTA) according to the received external vendor data and performed external vendor reconciliations like lab, IRT, PK, ERT Echo reconciliations
- Reviewed and performed the query management activities by addressing the open queries and reporting the issues
- Drafted Data Review Plan outlining the method, criteria, and frequency of review conducted by each function across the study team
- Maintained laboratory reference ranges and reconciled with lab data
- Reviewed and fixed discrepancies found by automated or manual checks
- Generated regular metrics reports, clean patient tracker and data listings for team review
- Cleaned and locked data for interim analysis and final database lock
Associate Clinical Data Manager
IQVIA
Bengaluru, Karnataka
08.2019 - 07.2021
- Performed all CDM functions in compliance with the regulations and company SOP
- Participated in study start-up, validation, and implementation of the clinical database
- Performed Clinical data Management activities in all the three phases of clinical trials (PhaseI,II and III)
- Responsible for prompt, proper and accurate data entry in the various EDC Systems
- Participated in the execution of edit check test plans and UAT
- Testing of the screens and executing validation procedures
- Participated in Study-conduct phases like setting up Data Transfer Agreements (DTA), Query Management and Reconciliations
- Performed lab data reconciliations, IRT reconciliations, all SAE reconciliations and worked closely into safety
- Participated in Quality Control data in CRFs in various studies
- Query management tasks are performed by resolving the queries and re-queried when appropriate while performing data review and discrepancy management through various external reconciliations
- Participated in developing the Data Validation Plans for finding out discrepancies through edit check programs
- Assisted with locking, transferring, and archiving of study databases.
Education
Master of Science - Biotechnology
University of Houston - Clear Lake
Houston, TX12-2022
Bachelor of Science - Pharmacy
Jntuh
Hyderabad, India03-2020
Skills
- GCP
- EDC
- CDISC,CDASH
- SAS
- J-Review and Spotfire
- MS project, Excel
Achievements and Certifications
- Participated in 9TH INDO-MALAYSIAN CONFERENCE (gstd4-2019).
• Completion of INDUSTRIAL TRAINING at goldfish pharma Pvt. Ltd.
• Certification in advanced training in clinical research and management including pharmacovigilance and medical writing from CLINIINDIA. • NIH GCP Certification
• Medidata Rave EDC Certification : Data Manager
Timeline
Clinical Data Manager
Insight Clinical
08.2022 - Current
Associate Clinical Data Manager
IQVIA
08.2019 - 07.2021
Master of Science - Biotechnology
University of Houston - Clear Lake
Bachelor of Science - Pharmacy
Jntuh