Pratik Saraf
Kitchener,ON
Summary
Pursuing Business Management from Georgian@ILAC college which is expected to complete by the end of December 2023. Well-qualified Clinical Data Specialist successful at building and maintaining secure, accurate and efficient data collection systems. Hardworking and pragmatic with strong attention to detail and methodical approach. Prepared to offer 4.5 years of experience to fast-paced position with room for advancement.
Overview
4
4
years of professional experience
Work History
Clinical Data Specialist
IQVIA RDS (India) Private Limited
10.2020 - 03.2022
- Experience in working on COVID - 19 studies
- Responsible for Edit Checks Testing for EDC studies on Medidata Rave
- Performed UAT of eCRF
- Performed reviewing of Clinical Data Listings to ensure data quality and protocol compliance
- Worked on lab/sample reconciliation
- Performed Data Cleaning/Discrepancy Management
- Performed database Lock.
- Enforced strict data validation rules to maintain accuracy and completeness of clinical data.
- Worked with programming to coordinate Study Data mappings.
- Managed time efficiently in order to complete all tasks within deadlines
- Worked effectively in fast-paced environments
- Built complex data analysis reports and provided timely feedback to stakeholders
- Assisted with database upgrades and migrations by performing user acceptance testing
Clinical Data manager
Cognizant Technology & Solutions
11.2019 - 10.2020
- Experience in working on Ophthalmological and Oncology studies (Setup, Conduct and Close-out)
- Responsible for creation of Edit Checks Specifications and Edit Checks Testing for EDC studies on Medidata Rave
- Responsible for writing of CCI (CRF Completion Instructions) document
- Coordinated CRF design as per study requirements and Protocol
- Performed UAT of eCRF
- Responsible for reviewing Clinical Data Listings to ensure data quality and protocol compliance
- Performed Data Cleaning/Discrepancy Management
- Coordinated with study team and onsite data manager for smooth conduct and timely delivery of study activities
- Performed Locking of studies.
Clinical Data Reviewer
Tata consultancy services
07.2018 - 11.2019
- Experience in working on Ophthalmological studies and Malaria Vaccine studies
- Reviewed IDRP and providing comments as per protocol
- Worked on validation writing plan and performed QC for same
- Performed validation plan writing and testing of edit check
- Worked on discrepancy management within timeline on Inform Database and Medidata Rave
- Worked on reconciliation lab and SAE
- Coordinated with CRA, Monitor and Onsite Data Manger via call and email on issues related to study
- Suggesting few SAS and edit checks which are needed for study as per protocol.
Education
Post-Graduate Diploma - Business Management
Georgian College
Toronto, ON12.2033
Post-Graduate Diploma - Project Management
Conestoga College
Kitchener, ON12.2022
B. PHARMA -
Acropolis Institute of Pharmaceutical Education And Research
India2017
Higher Secondary - High School
Padmaja H.S. School
India2013
Senior Secondary -
Vindhyachal Academy
India2010
Skills
- Clinical Data Management
- Microsoft Office
- Data Validation
- Data Integrity
- User Acceptance Testing
- Medidata Rave
- Inform Database
- CRF Completion Guidelines
- Discrepancy Management
- Database Lock
- SAS Checks
- Edit Checks
Timeline
Clinical Data Specialist
IQVIA RDS (India) Private Limited
10.2020 - 03.2022
Clinical Data manager
Cognizant Technology & Solutions
11.2019 - 10.2020
Clinical Data Reviewer
Tata consultancy services
07.2018 - 11.2019
Post-Graduate Diploma - Business Management
Georgian College
Post-Graduate Diploma - Project Management
Conestoga College
B. PHARMA -
Acropolis Institute of Pharmaceutical Education And Research
Higher Secondary - High School
Padmaja H.S. School
Senior Secondary -
Vindhyachal Academy
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