Summary
Overview
Work History
Education
Key Skills And Achievements
Timeline
Generic

SHAZIA SHAMSHAD

Pratapgarh

Summary

About 7 years of experience in Clinical Data Management as Clinical Coder to work efficiently on coding activities during Setup, Conduct and Close-out phases. Excellent knowledge on MedDRA, WHODrugGlobal and ATC Coding. Robust experience of working with a wide range for clients, for projects based on different indications and therapeutic areas under different phases of clinical testing utilizing different database systems.

Overview

7
7
years of professional experience

Work History

Clinical Data Coder 2

Parexel International
03.2020 - Current

Accountability and Supporting Activities

Clinical Coding:

  • Perform task as Lead coder of assigned projects and meet the deliverables on time.
  • Perform clinical coding activity using standard coding dictionaries e.g.

MedDRA, WHODrug and other sponsor customized ones, following coding guidelines/conventions.

  • SAE Reconciliation, Coding Query Management.
  • Identify and report issues with coding and EDC system synchronization.

Coding Set up, Reports and Documentation:

  • Data coding Guidelines preparation, Test data entry, Coding tool setup and Validation, and assist in Technical peer review and functional QC activities of coding set up.
  • Author, review and maintain coding related documents and coding reports, and filing in eTMF.

Dictionary Management and Database Lock activities

  • Dictionary Upgrades, Synonym upgrade validation, identify and report discrepancies with clinical dictionary used.
  • Ensure high quality coding data delivery for major milestones.

Project Management & Compliance

  • Performing/ Leading functional Coding activities
  • Assist in developing/updating metrics/ dashboard for coding team.
  • Lead Coder for multiple projects
  • Assist in training/mentoring new hires to support growth and development and apply high-quality coding practices.
  • Comply with Applicable SOPs, regulatory requirements (e.g. ICH-GCP), manuals trainings and best practices.
  • Assisted with development of internal coding guidelines and procedures, ensuring consistency and accuracy across the project.

Junior Data Analyst-Medical Coding

Cognizant Technology Solutions
12.2016 - 02.2020
  • Accountability and Supporting Activities: Coding and query management activities. Coding metrics and trackers generation and maintenance. Conduct knowledge sharing session. SAE reconciliation and coding consistency.

Education

Advanced Diploma in Clinical Research -

Academy For Clinicals Excellence, BCP
Mumbai
2016

MBA - Hospital Administration

Sikkim Manipal University
Distance Education
2014

Bachelor of Physiotherapy -

Prabhat Institute of Paramedical Science Allahabad
Affiliated From Agra University
2011

Key Skills And Achievements

  • Client Management - Developing and strengthening relationship with the client.
  • Project Management - Ensure timely and high-quality deliverables.
  • Team Management - Accountable for effective resource utilization as a lead coder, issue escalation & resolution, and implementation of process improvements.
  • Expertise in Coding activities- Data coding document preparation, Test data entry, Coding tool setup and Validation, Dictionary Upgrades, Synonym upgrade validation, MedDRA & WHO-Drug Coding and ATC coding. Coding Review and Reports, SAE Reconciliation, Coding Query Management.
  • Expertise in Coding Systems- Having Enriched experience on CDMS platforms and coding tools like Medidata Rave, Rave Workbench, Inform central coding, Veeva CDMS, DS Navigator, Datalabs and PACE.
  • Trainer & mentor - Assist in training/mentoring new hires.
  • Certification- Achieved MedDRA Certified Coder certification.
  • Communication skills- Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas.
  • Other Professional skills- Learning ability and knowledge sharing approach; swift understanding of technologies and new processes.

Demonstrates attention to detail and commitment to First Time Quality. Strong interpersonal, verbal and written communication skills.

Strong analytical and problem-solving skills, including ability to conduct root cause analyses.

Good Time management skills, ability to plan & prioritize tasks in order to meet objectives and timelines

Timeline

Clinical Data Coder 2

Parexel International
03.2020 - Current

Junior Data Analyst-Medical Coding

Cognizant Technology Solutions
12.2016 - 02.2020

Advanced Diploma in Clinical Research -

Academy For Clinicals Excellence, BCP

MBA - Hospital Administration

Sikkim Manipal University

Bachelor of Physiotherapy -

Prabhat Institute of Paramedical Science Allahabad
SHAZIA SHAMSHAD