Summary
Overview
Work History
Education
Skills
Accomplishments
Authentication
Timeline
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Harsha Chaudhari

Harsha Chaudhari

Thane

Summary

Skilled in team collaboration, decision-making, and mentoring new hires to enhance project alignment and performance. Dynamic professional experienced in clinical data management, with a focus on optimizing workflows and ensuring data integrity. Known for effective communication and problem-solving skills, contributing to successful project outcomes and fostering team development.

Overview

8
8
years of professional experience

Work History

Study Data Manager

TCS
Thane
06.2018 - Current
  • Coordinated with cross-functional teams to optimize data management workflows
  • Lead data management activities for multiple global clinical trials, from start-up to database lock.
  • Mentor and guide new hires and junior team members to ensure technical competence and project alignment.
  • Participate in important study meetings
  • Organize knowledge sharing sessions and feedback calls
  • Act as primary point of contact for internal teams and external stakeholders to ensure smooth communication and issue resolution.
  • Met the deliverable with quality and as per the client requirements.
  • Provide technical expertise to Clinical Data Management
  • Own and manage post-production development, including change requests and functional enhancements.
  • Contribute to process improvement initiatives, helping to standardize and streamline CDM operations across studies.
  • Plan and manage study timelines, delegate tasks, and oversee deliverables through internal tracking systems, and weekly status reviews.

Junior Data Analyst

Cognizant Tech Solutions
Thane
07.2017 - 06.2018
  • Developed dashboards and metrics using data visualization for presentation to the client.
  • Performed CDM activities in all phases of clinical trials.
  • Conducted data cleaning and validation to ensure accuracy.
  • Performed set-up activities, such as writing checks in DVS, eCRF specifications as per protocol requirements, UAT, and test script writing.
  • Mentoring new joiners for technical support and knowledge sharing.
  • Coordinated Change request management post go-live
  • Cleaned, organized and transformed raw data into meaningful information for reporting purposes.
  • Discrepancy review, query generation, resolution, and simultaneous communication with CRAs.
  • Reviewed validation listings generated from SAS outputs to ensure accuracy in protocol-critical variables.
  • Conducted SAE reconciliation between clinical data and safety systems to ensure patient safety data integrity.
  • Performed third-party vendor data reconciliation, working with central labs, and ECG vendors to identify and resolve data mismatches.

Education

Master of Pharmacy - Pharmacology

Dr. L. H. Hiranandani College of Pharmacy
Mumbai
05-2013

Batchelor of Pharmacy -

NCRD's Sterling Institute of Pharmacy
Mumbai
05-2011

Skills

  • Soft Skills - Decision making, Communication, Observation, multi-tasking
  • Hard Skills - MS office, Medidata Rave, InForm, SAS Basic fundamentals

Accomplishments

  • Best Team Award, Milestone Achievement Award, Star of the Month Award, Client Appreciation.

Authentication

Information mentioned in the document is accurate as per my best knowledge.

Timeline

Study Data Manager

TCS
06.2018 - Current

Junior Data Analyst

Cognizant Tech Solutions
07.2017 - 06.2018

Master of Pharmacy - Pharmacology

Dr. L. H. Hiranandani College of Pharmacy

Batchelor of Pharmacy -

NCRD's Sterling Institute of Pharmacy

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Harsha Chaudhari