Summary
Overview
Work History
Education
Skills
Languages
Timeline
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Tahireen Khan

PUNE

Summary

  • Seeking Challenging career to utilize my knowledge into 'Clinical Research Domain'.
  • Competent Professional with 3.9yrs of experience in core clinical data Management in set up,conduct and close out Phase.
  • Subject Matter champion in Query Management,Lab Management &2Reconcilation.
  • Experience of working For Oncology,Cardiovascular & Dermatology therapeutic area using Medidata Rave & I_Medidata, Rave X & Rave Classic database.

Overview

5
5
years of professional experience

Work History

Sr. Clinical Data Coordinator

IQVIA
04.2023 - Current
  • Summary - Document Preparation,Query Management,Discrepancy Management,Data Review,Attending Monthly Clients and Weekly DM calls,Lab Management,Interim analysis or Snapshot,Reconciliation.Database lock,Database lock,Database Freezing,PI Signature,UAT-Edit check testing,DTS,ECS,DMP,Global QDR etc
  • Experience in using Data Management tools like Medidata Rave Classic and Medidata Rave X.
  • Written,oral & Virtual communication with the client,study team and vendor globally.
  • Provides Training and resolving doubts of Team members of activities.
  • Startup Phase: Creation draft Cope of DM,Attending Kickoff meetings,Performing various types of UAT like screen Testing,Edit Check Testing, LNR UAT,CCG & PD UAT
  • Conduct Phase: Query management(Answered Queries),Data Review for system and Manual queries. Manual Data listings,DM review ,Forms Inactivation,Missing page report,Protocol deviation & EPRO Reconciliations,Vendor reconciliations. Worked on Multiple studies for Rainbow Project from OC_RDC to Rave_EDC,Final Data base QC activities. Preparing Metrics Report,Organizing fun learning activities,POC'S for compliance task. DQPM checks.
  • Closeout Phase: Prepare trackers for Study Closure,QC for End of study,Fol,lowing the Database lock checklist activities and performed accordingly.
  • Send various reports to the study team on a regular and weekly basis(Answered and open Queries reports etc).

Clinical Data Associate 2

Syneos Health (inVentiv) - Endo Pharmaceuticals
08.2019 - 11.2022
  • Summery:- Managing the Portfolio of global client across Oncology.Document Preparation,Query Management Discrepancy Management, Data Review,Attending Monthly Clients and weekly DM Calls,Lab Management,Interim analysis or Snapshot. Reconsicillation,Database lock,Data base Freezing,PI Signature.
  • Performed external Data & SAE Reconciliation.
  • Core CDM tasks like: Query management,DM review ,Database Lock etc.
  • Major Achievements of working on COVID Studies with in the set Timelines.
  • Experience in using Data Manager tools like - Rave,I-Medidata,Spotfire,ETMF,UATME Etc.
  • Resolving doubts of team members for DM activities and allocation of study activities to punctual delivery of projects.
  • Communication with Clients,Vendor,Study Team & Site Team.
  • Understanding Protocol,ECRF Guidelines & Perform manual review along with Query Management to ensure error free,quality data & complete the tasks as per timelines.
  • Conduct Phase: Query Management (QDR,PSAT,Spotfire data review checks,Gdoc. Sheet Queries etc),J review, Missing page,until & Lab report,Lab Entry Lab Qc,MLN,MLR(Local & COVID labs)Normal ranges,SVS Lab data review,SAE Lab data review (GDSR,Range Accuracy checks etc),manual listing,Exception report, DM review,SAE reconciliations & third party reconciliations,Performing Review of discrepancy (Edit checks)Output & validation Listings based on data entry on the clinical database. Resolving answered query& re-query where appropriate. Preparing Check list,Maintaining reports(Review log/Training Logs)as per GDO,creating Electronic,Storage media per SOPs for every Studies.
  • Give Trainings to team members ever Monthly.
  • Closeout: Cleaning Data,Database subjects for PI Signature,Maintaining Patient Tracker Sheet,Following the Database lock checklist activities & performed Accordingly.

Education

MSC (Clinical Research) -

Institute Of Clinical Research India
MUMBAI, India
2019

BSC(Microbiology+Voc,Biotechnology) -

University Of Pune
Pune
2016

Associate of Science -

HSC Board
Pune
2013

10th -

SSC Board
Pune
2011

Skills

  • Excel Formulas(Vlookup,Concatenate etc)
  • Problem Solving
  • Communication Skill
  • Familiar with Medical Terminology
  • Familiar with all Clinical Research Documents
  • RECIST 11

Languages

English
Advanced (C1)
Marathi
Advanced (C1)
Hindi
Advanced (C1)

Timeline

Sr. Clinical Data Coordinator

IQVIA
04.2023 - Current

Clinical Data Associate 2

Syneos Health (inVentiv) - Endo Pharmaceuticals
08.2019 - 11.2022

MSC (Clinical Research) -

Institute Of Clinical Research India

BSC(Microbiology+Voc,Biotechnology) -

University Of Pune

Associate of Science -

HSC Board

10th -

SSC Board

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