Summary
Overview
Work History
Education
Skills
Awards
Disclaimer
Timeline
Generic

Vishal Bongoni

Sr. Clinical Data Associate
Karimnagar,TG

Summary

Experienced clinical research professional skilled in managing and validating clinical data for research studies. Recognized for meticulous attention to detail, ensuring data accuracy and integrity. Collaborative team player with a strong focus on achieving project goals and adapting to changing project requirements. Proficient in data management software and knowledgeable in regulatory compliance standards.

Overview

7
7
years of professional experience
4
4
years of post-secondary education

Work History

Senior Clinical Data Associate

Syneos Health
12.2020 - Current
  • Oversee data management activities from study setup to database lock, ensuring quality and timelines.
  • Work with the Clinical Data Strategist to ensure data collection aligns with the study protocol.
  • Create and update the Data Management Plan (DMP) throughout the study.
  • Lead data cleaning efforts and review data to ensure it is accurate and consistent.
  • Suggest and support updates to the clinical database after go-live.
  • Prepare and maintain plans for key study deliverables (e.g., data quality and lock timelines).
  • Provide expert guidance on data management processes and best practices.
  • Support audit and inspection readiness, representing clinical data sciences as needed.
  • Apply knowledge of regulatory requirements (e.g., FDA, ICH, GCP) to ensure data compliance.
  • Performing UAT, developing edit check specifications and managing timelines.
  • Performing SAE, Lab and IWRS recons on agreed frequencies and coordinating with vendors to resolve issues.
  • Conducting regular data review meetings to address Permanent issues, Critical data and aging query resolutions.
  • Utilizing Spotfire for monthly data listing reviews, ensuring accuracy and compliance.
  • Tracking project progress and preparing periodic status reports and metrics.
  • Conducting lessons learned meetings on portfolio level.

Associate Clinical Data Coordinator

IQVIA
05.2018 - 12.2020
  • Led holistic data reviews for subjects enrolled in Anemia and Respiratory therapeutic studies.
  • Implemented Study Specific Data Management Plans (DMP) and conducted edit checks.
  • Managed data cleaning activities including Query Management and reconciliation (LAB, SAE, PK).
  • Supported database locking processes and reviewed SAS and DRT listings monthly.
  • Ensured high-quality data submissions from investigative sites through rigorous reviews.
  • Conducted thorough quality control procedures to uphold data accuracy and consistency.
  • Generated reports and managed clinical data listings effectively using available tools.

Education

Bachelor of Pharmacy -

Sree Chaitanya Institute of Pharmaceutical Sciences
Karimnagar, Telangana
01.2013 - 01.2017

Skills

  • RAVE and INFORM database
  • J-Review
  • Spotfire SAS listings review
  • Veeva Vault eTMF
  • Study management tools, CPT dashboard, Metrics
  • Microsoft office (Word, Excel, Power BI, PowerPoint presentation etc)
  • Therapeutic areas: Hematology, Neurology, Oncology, Infection-COVID 19
  • FDA, ICH guidelines
  • Good Communication skills
  • Presentation skills

Awards


  • Received Roche excellence award for continuous support in achieving Overall Survival analysis (01/01/25) for one study.
  • Received Recognition Awards from Syneos Say Thanks Program (06/01/22, 08/01/22, 10/01/22, 04/01/23, 08/01/23, 02/01/24).
  • Recognized twice in IQVIA Impact Program (2018, 2019).
  • Successfully led database lock for one study at IQVIA (03/01/20) and Syneos (07/01/23).

Disclaimer

I, hereby declare that all the above furnished information is true to the best of my knowledge and belief.

Timeline

Senior Clinical Data Associate

Syneos Health
12.2020 - Current

Associate Clinical Data Coordinator

IQVIA
05.2018 - 12.2020

Bachelor of Pharmacy -

Sree Chaitanya Institute of Pharmaceutical Sciences
01.2013 - 01.2017

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Vishal BongoniSr. Clinical Data Associate