Summary
Overview
Work History
Education
Skills
Websites
THERAPEUTIC AREA EXPERTISE
People Skills
Activities
Timeline
Generic
Harika Pilli

Harika Pilli

Chennai

Summary

With over 6+ years of experience in Clinical Data Management, I have gained valuable hands-on experience in various activities spanning the Study Start-up, Conduct, and Close-out phases across multiple therapeutic areas in all Phases of Clinical trails. The core focus has been on maintaining the integrity, accuracy, and compliance of clinical trial data. I possess a high level of proficiency in working with the Medidata Rave and Rave X platforms.

Overview

6
6
years of professional experience

Work History

Clinical Data Analyst-II

PAREXEL
08.2022 - Current
  • Currently working on Phase IV study in Cardiology and Phase I, II study in Oncology therapeutic areas
  • Working for two Study start-up activities as a support.

Data Coordinator

PREMIER RESEARCH
10.2020 - 08.2022
  • Worked on 3 studies as a lead data coordinator, Phases I and III study in therapeutic area of Neurology and one Phase II in therapeutic area of Dermatology
  • Have been mainly involved in conduct and close out phases.

Clinical Data Specialist

IQVIA
03.2018 - 10.2020
  • Worked on 4 Phase 1 Clinical Trail (Early Development) in therapeutic area of Oncology with less than 3 supporting reviewers
  • Worked in study conduct and close out phases.

Education

B-PHARMACY -

NRI COLLEGE OF PHARMACY, AGIRIPALLI(M), KRISHNA DISTRICT - JAWAHARLAL NEHRU TECHNOLOGY UNIVERSITY KAKINDA-AP
Vijayawada
05.2017

INTERMEDIATE -

NRI JUNIOR COLLEGE, VIJAYAWADA -BOARD OF INTERMEDIATE EDUCATION, AP
Vijayawada
05.2012

Skills

  • Query Management and Query Quality Review
  • Central and Local Lab data Reconciliation
  • Listings review
  • Data Validation Specifications
  • UAT
  • TMF QC
  • Protocol Deviation management
  • Metrics
  • Stats Issue Log Maintenance
  • Database Revision Requests
  • SAE Reconciliation
  • CRF Guidelines Preparation
  • Drafting listing specifications
  • Medical listings review
  • Lab ranges set up
  • Reviewing Inactivated pages
  • Non-Conformant data
  • Unsubmitted data points
  • Unsubmitted Unforecasted pages
  • Mentored and trained team members
  • Basic quality control procedures on all CDM activities as per standard operating procedures (SOPs)
  • Attending study meetings on regular basis and supporting leads in Ad-hoc activities
  • Effectively communicates with reviewers and leads on regular basis to ensure project timelines and milestones are met in time for given projects

Websites

THERAPEUTIC AREA EXPERTISE

  • Oncology
  • Cardiovascular
  • Immunology
  • Hematology
  • Dermatology
  • Neurology
  • Orthopedics
  • Endocrinology
  • Autoimmune Diseases

People Skills

• Have knowledge on CDISC Standards, ICH-GCP and GCDMP.
• Basic knowledge on RECIST 1:1 and Working knowledge on MS Office, Word, Excel, Outlook, PowerPoint.
• Working under stress with polite attitude and open to feedback.
• Good at Time management and Project Management skills.

Activities

  • Received recognitions and certificates for successfully completing DB lock and Snapshots for various studies.
  • Registered Pharmacist under Andhra Pradesh State Pharmacy Council (Reg no.1275/5/A1).

Timeline

Clinical Data Analyst-II

PAREXEL
08.2022 - Current

Data Coordinator

PREMIER RESEARCH
10.2020 - 08.2022

Clinical Data Specialist

IQVIA
03.2018 - 10.2020

B-PHARMACY -

NRI COLLEGE OF PHARMACY, AGIRIPALLI(M), KRISHNA DISTRICT - JAWAHARLAL NEHRU TECHNOLOGY UNIVERSITY KAKINDA-AP

INTERMEDIATE -

NRI JUNIOR COLLEGE, VIJAYAWADA -BOARD OF INTERMEDIATE EDUCATION, AP

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