Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

Harshitha

Sanford,FL

Summary

  • Clinical Data Management professional with over 6 years of experience leading multiple studies through comprehensive planning and execution. Proven expertise in study start-up, conduct, and close-out activities, coupled with a strong capability in preparing e-Case Report Forms (eCRFs) and conducting User Acceptance Testing (UAT). Demonstrated success in data validation, query trend analysis, and maintaining Trial Master Files (TMF), with therapeutic knowledge spanning Cardiovascular disease, Respiratory disease, Oncology, Endocrinology, and Central Nervous System (CNS). Recognized for exceptional analytical skills and ability to foster collaboration across cross-functional teams while mentoring junior staff.

Overview

6
6
years of professional experience

Work History

Senior Clinical Data Manager

TK-CHAIN LLC
11.2022 - Current
  • Company Overview: IQVIA
  • Communicate effectively with internal stakeholders, such as clinical operations, biostatistics, and medical affairs teams, as well as external stakeholders, including study sponsors and regulatory authorities, to ensure alignment and transparency throughout the data management process
  • Assisted in the development and implementation of data management plans for multiple clinical trials
  • Developed, reviewed, and maintained trial-specific data management documents including data management plans (DMP), data review plan, CRF completion guidelines, data validation plan (DVP) and external data transfer agreements throughout the life cycle of the project and ensured adherence to the project requirements
  • Review and manage key data management documents and specifications, including eCRF completion guidelines, dictionary coding specification, and data management plans
  • Oversee eCRF and data validation specification development and manage internal, cross-functional review
  • Led the development of data edit check specifications and data listings
  • Underwritten to the Request for Proposal (RFP) and Request for Information (RFI) Process
  • Perform user acceptance testing (UAT) of eCRF screens and programmed edit checks
  • Perform periodic data and coding review to identify quality issues and general data trends
  • Develop Case Report Forms (eCRFs), Data Validation Plans (DVP), CRF completion guidelines (CCG)
  • Manage CRO timelines and coordinate cross-functional feedback to achieve timely delivery of data extracts in support of deliverables
  • Implemented and maintained data auditing reports, metrics, and tracking reports
  • Liaise with laboratory and safety vendors to ensure appropriate data transfer agreements in place and for data transfers reconciliation between external and clinical databases
  • Created project plan for DM function by taking inputs from Programming and Coding teams
  • Provided input into the development of data management SOPs and processes
  • Supported database setup and user acceptance testing (UAT) activities for electronic data capture (EDC) system
  • IQVIA

Clinical Data Manager

AstraZeneca
07.2020 - 10.2022
  • Apply relevant components of the project protocol to daily tasks and direct others on how to apply to their daily tasks
  • Extensive hands-on experience during study conducts on validation of data, cleaning the data, Discrepancy management, Lab Reconciliation and SAE Reconciliation
  • Worked extensively on study closing activities including Data Review, Data freezing and Study Lock
  • Assisted in performing clinical data interim analysis
  • Effectively communicated project status and timelines with the project team, study lead, project lead, project manager and other cross functional groups
  • Led assigned data processing and management projects
  • Managed timelines and coordinated activities for assigned projects
  • Monitor and analyze study metrics and escalates per the organization’s risk management processes
  • Experienced with CIDSC SDTM Standards
  • Effectively managed the team and acted as Point of Contact between Onshore and Offshore teams
  • Review, validate and analyze clinical trial data ensuring data consistency and accuracy
  • Cooperated and assisted, when required, data management quality assurance (QA) personnel in performing QA procedures on trial CRFs, database schema and databases for assigned studies
  • Maintained comprehensive documentation of data management activities, including data management plans, validation documentation, and audit trails to support regulatory submissions and inspections

Clinical Data Co-ordinator

CLINICA MAPLETREE ANALYTICS
08.2018 - 05.2020
  • Reviewed clinical study Protocol and coordinated as well as performed the collection and processing of CRF data
  • Ensured data management activities, including data receipt, data entry, initial and final data review, and discrepancy resolution
  • Sound knowledge about manual and automated methods to perform clinical data review and medical review for the overall integrity and consistency of the clinical trial data
  • Recognized uncoded terminology entered the database and coordinated with appropriate teams and ensured accurate coding using MedDRA and other dictionaries
  • Identified and resolved lab data quality issues and maintained standard central and local data management practices
  • Warranted consistency in execution across assigned trial portfolio

Education

Bachelor of pharmacy -

Jawaharlal Nehru Technological University
Telangana, India

Skills

  • Medidata Rave
  • InForm
  • Data Labs
  • OC RDC
  • PheedIt
  • Clintrail
  • Oracle Clinical
  • MS Office Word
  • Excel
  • Access
  • Power Point
  • CDISC/CDASH
  • SDTM
  • MedDRA
  • WHO Drug
  • GCP/ICH
  • 21 CFR part 11
  • Base SAS
  • Oncology
  • Cardiology
  • Gastrointestinal Tract
  • Respiratory diseases
  • Dermatology
  • Medical devices
  • I-review
  • J-review

Accomplishments

  • Successfully managed multiple clinical trials simultaneously, resulting in timely database locks and high-quality data.
  • Implemented a data quality metric program, resulting in a 25% reduction in data queries.
  • Collaborated with the biostatistics team to develop a standardized data validation plan, resulting in improved data quality and reduced timelines.

Timeline

Senior Clinical Data Manager

TK-CHAIN LLC
11.2022 - Current

Clinical Data Manager

AstraZeneca
07.2020 - 10.2022

Clinical Data Co-ordinator

CLINICA MAPLETREE ANALYTICS
08.2018 - 05.2020

Bachelor of pharmacy -

Jawaharlal Nehru Technological University

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