Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Pragati Chavan

CLINICAL DATABASE DESIGNER/DATA MANAGER
Select,09-Delhi

Summary

Certified Clinical Database Designer with 10+ years of experience adept at increasing work process efficiency and profitability through functional and technical knowledge of study setup and conduct activities. Areas of expertise include early phase and late phase trial designing, data management, query management, data validation and listings specification creation.

Overview

11
11
years of professional experience
8
8
years of post-secondary education
1
1
Certification

Work History

Senior Clinical Database Designer

IQVIA
Mumbai
01.2021 - Current
  • Interpret clinical study protocol and provide inputs to relevant stakeholders/sponsors.
  • Design Phase 1 to Phase 4 clinical trials based on clinical study protocol which includes various therapeutic areas. Build study structure in Rave. Performed study migration activities. Providing Impact to Sponsor.
  • Maintain and use various sponsor and in house libraries.
  • Identify and draft relevant manual review listings in SAS spec and other platforms.
  • Involved in creation and maintenance of training material, process trainings and associate mentoring.
  • Programming of simple edit checks and testing Edits, CF and backend listing.

Business Process Lead

Tata Consultancy Services Ltd
Mumbai
2 2015 - 12.2020
  • Worked as Associate Study Data Lead for assigned studies and POC for Sponsor from data management team for multiple studies
  • Responsible for communicating with client on ongoing basis
  • Responsible for work allocation and performing QC of work performed by associates.
  • Managed studies in setup, conduct and close out phase. Good working knowledge of Clinical Trials data and proficiency in Medidata Rave.
  • Handled query management which involves: Raising manual queries, closing answered queries.
  • Responsible for reconciliation activities such as SAE reconciliation, Vendor Reconciliation and third-party data reconciliation e.g., Central lab data reconciliation.
  • Creation and maintenance of various study data reports including Query reports, Pages overdue reports, Patient clean tracker, Lab reports etc.

Clinical Data Analyst

RPM Alliance
12.2013 - 11.2014
  • Communication with Sponsor (POC) for Reporting requirements of studies.
  • Created weekly reports to provide details for data cleaning activities and overall study status including data listings in required format as and when needed.
  • Performed Medical Coding activities on assigned project in a timely and efficient manner
  • Generating queries to resolve inconsistencies in Manual/Coding related data.
  • Trained on study specific Query management and SAE Reconciliation activities
  • Participated in Client Audit.

Education

Master of Science - MSc. Applied Pharmaceutical Microbiology

School of Pharmacy And Technology Management, Narsee Monjee Institute of Management Studies
India
06.2010 - 08.2012

Bachelor of Science - BSc. Microbiology

Nagindas Khandwala College, Mumbai University
Mumbai
07.2007 - 01.2010

Associate of Science - H.S.C

Thakur College of Science And Commerce, Mumbai University
Mumbai
06.2005 - 07.2007

High School - S.S.C

St. Lawrence High School, Maharashtra State Board
Mumbai
01.2005 - 12.2005

Skills

Proficient in MS-Office tools such as Excel and Word

Time Management

Critical Thinking and Effective Communication

Teamwork

Certification

Rave Database Designer

Timeline

Senior Clinical Database Designer

IQVIA
01.2021 - Current

Clinical Data Analyst

RPM Alliance
12.2013 - 11.2014

Master of Science - MSc. Applied Pharmaceutical Microbiology

School of Pharmacy And Technology Management, Narsee Monjee Institute of Management Studies
06.2010 - 08.2012

Bachelor of Science - BSc. Microbiology

Nagindas Khandwala College, Mumbai University
07.2007 - 01.2010

Associate of Science - H.S.C

Thakur College of Science And Commerce, Mumbai University
06.2005 - 07.2007

High School - S.S.C

St. Lawrence High School, Maharashtra State Board
01.2005 - 12.2005

Business Process Lead

Tata Consultancy Services Ltd
2 2015 - 12.2020

Similar Profiles

CREATE PROFILE
Pragati ChavanCLINICAL DATABASE DESIGNER/DATA MANAGER