Dedicated to using excellent research, investigation and project management abilities to optimize management, organization and reporting of clinical data. Results-driven, precise and systematic with quick learning and collaborative nature. Strong history of working with top Clinical research Organizations (CROs).
Hi, I’m
Sachin Chaudhary
Mumbai
Summary
Overview
12
years of professional experience
Work History
LabCorp
Senior Clinical Data manager
09.2019 - Current
Job overview
- Performed project start-up, Conduct and Close out activities
- Attended Sponsor-FDA audit for recently locked study as organization representative in Audit
- Review clinical trials data in accordance with [Global] Data Management Plans and applicable standardized data management processes
- Generate, resolve and track queries to address problematic data identified during data review
- Perform study migration (change controls), UAT and Testing of Database, Validation of checks and listings
- Detailed experience in study migration (change controls) and budgeting for study activities
- Perform reconciliation of clinical and safety databases(SAE), reconciliation of central laboratory and/or third party vendor data (Electronic Case Report Form, Electronic Diary)
- Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved
- Experience in drafting Data Management Plan (DMP), Edit check Specification (ECS), SAE reconciliation plan, SAS check specifications, eCRF completion guidelines, Vendor data Plan
- Involved in development of clinical database, creation of data acquisition conventions and data review guideline
- Edit check specifications, development and testing of data management system edits and data validation checks and listings
- Interact and collaborate with other project and specialty team members such as clinical, programming, statistics, Clinical Data Management technical support, drug safety to support set-up, maintenance, and closure of data management aspects
IQVIA
Team leader
04.2017 - 09.2019
Job overview
- Worked as project leads for multiple studies for different clients and different therapeutic area
- To manage different therapeutic area and adherence with style guide and client specific conventions
- Managing team with delegating tasks and set deadlines, oversee day-to-day operation
- To perform quality check, prepare quality metrics
- Quality review of drafted documents for completeness, consistency and data integrity
- Team management and optimum utilization of resources along with project estimate, work allocation, project related documentation and queries
- Single point of contact for projects delivery and related activity.
Cognizant Technology Solutions
Data analyst
11.2013 - 03.2017
Job overview
- Communicate study data issues (data flow, discrepancies, etc.) with sites, Monitors and colleagues on study Data Management Team on daily basis
- Performed QC of data processing activities
- Worked on identifying SAE and reconciliations
- Worked on third party data reconciliations
- Performed activities according to database closure checklists in preparation for snapshot, efficacy analyses and database closures
- Involved in development of clinical database, creation of data acquisition conventions and data review guidelines, edit check specifications, development and testing of data management system edit / data validation checks and special listings
- Involved in Set up activity such identifying protocol specific checks, validations of edit checks
- Performed data review for patient locking in EDC data base
TATA Consultancy services
Senior Process Associate
12.2010 - 11.2013
Job overview
- Validation of Clinical Trial data to produce clean, reliable and complete report for Clinical Studies
- Performed discrepancy management in accordance with Study Data Quality Plan and according to agree upon timelines
- Review and resolve queries of Monitors/Scientist
- Communicate study data issues (data flow, discrepancies, etc.) with sites, Monitors and colleagues on study Data Management Team daily
- Performed QC of data processing activities
- Executes data listings programs and reviews for patient data consistency, quality and completeness as defined in Data Review Plan
- Performed activities according to database closure checklists in preparation for snapshot, efficacy analyses and database closures
- Performed data review of clinical data in EDC
Education
Maharashtra University of Health SciencesNashik
Master of Science from Pharmaceutical Medicine
08.2010
University Overview
Dr. D.Y.Patil Ayurveda CollegePune
Bachelor of Science from Bachelor of Ayurvedic Medicine And Surgery
04.2007
University Overview
Skills
- Data Quality
- User Acceptance Testing (UAT)
- Activities Management
- Standard Operating Procedures Understanding
- Client Assessments
- Team Communication
Accomplishments
Accomplishments
- Successfully achieved Go-Lives, Change controls and DBLs by completing Set-up, Conduct and Close-out activities with accuracy and efficiency.
- Awarded by Clients for accountability and proactive approach shown during the course of the study
Timeline
Senior Clinical Data manager
LabCorp
09.2019 - Current
Team leader
IQVIA
04.2017 - 09.2019
Data analyst
Cognizant Technology Solutions
11.2013 - 03.2017
Senior Process Associate
TATA Consultancy services
12.2010 - 11.2013
Maharashtra University of Health Sciences
Master of Science from Pharmaceutical Medicine
Dr. D.Y.Patil Ayurveda College
Bachelor of Science from Bachelor of Ayurvedic Medicine And Surgery
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