Summary
Overview
Work History
Education
Skills
Research Papers
Timeline
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Neha Savant

Team Lead - Clinical Reviewer

Summary

Detail-oriented and highly analytical Clinical Reviewer and Research Associate with 4 years of experience in reviewing clinical data, ensuring regulatory compliance, and supporting medical research projects. Proven ability to evaluate clinical documentation, identify discrepancies, and collaborate effectively with cross-functional teams to uphold data integrity and research quality. Skilled in literature review, protocol development, data analysis, and regulatory reporting. Committed to advancing clinical outcomes through accuracy, precision, and evidence-based research practices.


Overview

6
6
years of professional experience

Work History

Team Lead - Clinical Reviewer

Gravita Oasis Review Solutions Private Limited
03.2022 - 06.2024
  • Enhanced overall team performance by providing regular coaching, feedback, and skill development opportunities.
  • Educated team members on organizational mission and goals to enhance alignment and drive success.
  • Completed detailed documentation for each case reviewed, ensuring clarity for future reference and potential audits.
  • Used medical and clinical review guidelines and parameters to maintain consistency in MD review process, appropriate utilization levels and compliance with facility policies and procedures.
  • Established clear performance metrics for the team which helped in tracking progress towards set targets effectively.
  • Coached team members in techniques necessary to complete job tasks.
  • Evaluated employee skills and knowledge regularly, training, and mentoring individuals with lagging skills.
  • Maintained database systems to track and analyze operational data.

Research Associate (QC Auditor)

ACCUTEST RESEARCH LABORATORIES
10.2018 - 10.2020


  • To perform quality checks in clinical phase.
  • To perform in process and retrospective quality checks in clinical department.
  • Retrospective quality checking of study documents (Screening form, CRF,TMF).
  • To perform quality checks in different in-process activities like screening, ICF presentation, checkin, dosing, vital examination, check-out, poststudy, etc.
  • To report the finding in written to the concerned person.
  • To verify responses given with query generated.
  • To provide SOP training to other staff as and when required.
  • To check study related labels
  • To maintain all QC reports in file and archive them.
  • To request and maintain accountability of all study related documents.
  • To check all study related documents for its legibility, accuracy and completeness.
  • To solve QA/RA queries.
  • To conduct study initiation meeting.
  • To compile trial master file.
  • Any other administrative or system related activities has assigned by the head-clinical or Designee.
  • To help in report preparation

Education

MASTERS OF PHARMACY - Pharmaceutics

SIGMA INSTITUTE OF PHARMACY
Vadodara, India
04.2001 -

Bachelor of Pharmacy -

SIGMA INSTITUTE OF PHARMACY
Vadodara, India
04.2001 -

Skills

Regulatory guidelines expertise

Research Papers

Colon Targeted Moringa Gum Compression Coated Tablets of Capecitabin: A Factorial Approach

https://pharmacophorejournal.com/9edBABN


Optimization of floating bilayered tablets of Ketorolac Tromethamine: https://www.researchgate.net/publication/318655411_Optimization_of_floating_bilayered_tablets_of_Ketorolac_Tromethamine

Timeline

Team Lead - Clinical Reviewer

Gravita Oasis Review Solutions Private Limited
03.2022 - 06.2024

Research Associate (QC Auditor)

ACCUTEST RESEARCH LABORATORIES
10.2018 - 10.2020

MASTERS OF PHARMACY - Pharmaceutics

SIGMA INSTITUTE OF PHARMACY
04.2001 -

Bachelor of Pharmacy -

SIGMA INSTITUTE OF PHARMACY
04.2001 -

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Neha SavantTeam Lead - Clinical Reviewer