Summary
Skills
Work History
Education
Languages
Accomplishments
Overview
AccountManager
Open To Work

NILAYRAJU CHILAKA

Clinical Data Manager

Summary

Detail-oriented Clinical Data Manager with expertise in data accuracy, database management, and user acceptance testing. Proven ability to enhance clinical trial integrity and mentor new hires for project success.

Skills

  • Clinical data management
  • Database management
  • Clinical trial management
  • User acceptance testing
  • CRC compliance
  • Edit checks development
  • Vendor data management
  • Data accuracy
  • Problem solving
  • Mentoring new hires

Work History

Clinical Data Manager

Bristol Myers Squibb
Hyderbad
05.2025 - Current
  • Reviewed data for accuracy and completeness, ensuring high-quality deliverables throughout study phases.
  • Collaborated with cross-functional teams to ensure data integrity across all study phases.
  • Developed and tested edit checks for data entry database, improving reliability of report generation.
  • Generated user-based queries for review by statistical programmers before database lock.
  • Prepared detailed database specifications and data validation documents.
  • Managed daily queries and assessed external data for compliance with regulatory standards.
  • Created detailed specifications for data review, enhancing clarity and facilitating effective analysis for stakeholders.

Clinical Data Svs Analyst

Accenture Solutions Pvt. Ltd.
Hyderabad
03.2022 - 04.2025
  • Ensured accuracy and authenticity of clinical trial data by resolving discrepancies identified through system checks and manual reviews.
  • Executing Reports and Reviewing Data: Executing J-Review and eDM Reports, performing self-evident inspections according to PDRP or DRP standards, and tracking inconsistencies and query status using RAVE reports.
  • Conducted UAT checks for newly programmed listings, validating data accuracy and ensuring compliance with DRP or PDRP requirements before finalization.
  • Utilizing Technology for Data Handling: Utilizing technologies such as J-Review, RAVE, and CDW to handle external data provided by third-party vendors, ensuring seamless integration and accuracy.
  • Completed manual listings per PRDP or DPR guidelines, leveraging familiarity with RAVE database for effective data management and reporting.
  • Collaborated with data management leaders and project data managers in study team meetings to review updates and address outstanding issues.
  • Oversaw initial data transfer from vendors to ensure compliance with protocols and accurate integration into clinical trial systems.
  • Adhering to eTMF Compliance: Adhering to eTMF (electronic Trial Master File) document uploading standards, ensuring that all documents are correctly uploaded and accessible for review.
  • Completed the certification process for new hires to enter production, verifying that all new team members met the necessary standards and qualifications.
  • Mentored new hires, providing guidance during their onboarding process.

Education

M. Pharmacy - Pharmaceutics

PRABHATH INSTITUTE OF PHARMACY
Parnapalle, Nandyal
06-2024

B. Pharmacy - B. Pharmacy

Santhiram College of Pharmacy
Nandyal
09-2020

Languages

English
Upper Intermediate (B2)
B2
Hindi
Intermediate (B1)
B1

Accomplishments

Received the "Star of Business" award - in Accenture

Overview

4
4
years of professional experience

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NILAYRAJU CHILAKAClinical Data Manager