Summary
Overview
Work History
Education
Skills
Accomplishments
Disclaimer
Timeline
Generic

Kalpesh Valvi

Bachelor Of Pharmacy
Mumbai

Summary

Objective is to work for your company and utilize my abilities and experience in Clinical operations that can benefit the firm and contribute to my overall development as well as the Pharmaceutical and Healthcare Industry at large.

Experienced Clinical Trials Associate with history of working in the life science and services industry. Thorough knowledge of - ICH - GCP guidelines,and all the phases of the clinical trial study., Clinical Research, Systems like eTMF, CTMS, RAVE, and other vendor portals are used for clinical studies.

Overview

5
5
years of professional experience

Work History

eTMF Document specialist

TCS
09.2019 - 03.2021
  • Associate in Clinical Record Management and Clinical research field
  • Identification, naming, and categorization of all clinical and non-clinical documents, Splitting of all clinical documents
  • Good knowledge of ICH-GCP, Clinical research, and trials, 21CFR, and basic healthcare standards and regulations
  • Clinical Record Management, eTMF handling, a quality check of clinical documents, indexing, uploading documents in the eTMF system

Clinical Study Associate

TCS
09.2020 - 03.2021
  • Worked as Clinical Study Associate, assisting the Clinical operations department (Client) in Clinical trials right from Start up, conduct, and closeout
  • Worked in systems like CTMS, RAVE, IXRS, and eTMF for providing reports to vendors like Covance, and helped study teams in maintaining compliance in eTMF
  • Handling Access Management for the study team (GSM GSL)

Centralized Site Associate

IQVIA
09.2022 - Current
  • As a Centralized Site Associate I am collaborating with Global Clinical Trial Manager (CTM) on my assigned studies.
  • I am working on iMedidata RAVE and IBM EDC for performing 'Remote Data Review'. I raise query in EDC for any discrepancy in data entry as per Service Level Agreement. I have created and maintained project document 'Clinical data review plan' for performing data review. I raise query in EDC for any data discrepancy found and also look for potential Protocol Deviations while doing data review.
  • I am providing assistance to CRA for Monitoring Visits by creating 'Information Site Pack' which include all metrics of site.
  • I provide support to Global Clinical Trial Manager of adhoc project specific activities such as Protocol deviation reconciliation, Follow up Letter Compliance, Creating and maintaining study documents, eTMF document upload etc


Clinical Monitoring Operation Analyst

IQVIA
09.2022 - Current
  • I am also working as a CMOA in IQVIA. CMOA is responsible for collaborating with Global Executive team and provide Management team Metrics of Monitoring visits and studies on Weekly and monthly basis.
  • I have exposure to collaborate with Global Management team and also got Appreciation from them for my support on providing accurate and timely metrics

Education

Bachelor of Pharmacy -

Viva Institute of Pharmacy
Mumbai, India
06.2019

HSC -Maharashtra Board -

VIVA College of Science
Mumbai, India
04.2014

SSC- Maharashtra Board -

AVS Vidyamandir
Mumbai, India
04.2012

Advanced Post Graduate Diploma in Clinical Research & Pharmacovigilance -

Cliniminds
Mumbai, India
10.2022

Skills

Strong work ethicsundefined

Accomplishments

  • I received IQVIA Spotlight Award in April 2023 for my support to study and Management team.
  • I have received multiple appreciations from Global stake holder for my support on studies.

Disclaimer

I hereby declare that the above written particulars are true and correct to the best of my knowledge and belief

Timeline

Centralized Site Associate

IQVIA
09.2022 - Current

Clinical Monitoring Operation Analyst

IQVIA
09.2022 - Current

Clinical Study Associate

TCS
09.2020 - 03.2021

eTMF Document specialist

TCS
09.2019 - 03.2021

Bachelor of Pharmacy -

Viva Institute of Pharmacy

HSC -Maharashtra Board -

VIVA College of Science

SSC- Maharashtra Board -

AVS Vidyamandir

Advanced Post Graduate Diploma in Clinical Research & Pharmacovigilance -

Cliniminds

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Kalpesh ValviBachelor Of Pharmacy