Suparna Sinha
Newtown Kolkata
Summary
Focused on applying strong research skills toward improving data management, organization and reporting. Solid background with companies and to learn new systems, processes, and procedures quickly to maximize contributions. Highly collaborative and goal-oriented.
Overview
8
8
years of professional experience
Work History
Senior Clinical Data Specialist
FORTREA Drug Development
Kolkata
05.2023 - Current
- Worked on study Set up activity including DMP creation, CCG creation, DQRP creation, edit check assing and validation within database.
- Analyzed complex datasets to identify trends or patterns in the data.
- Developed procedures (using power BI) for organizing and filing clinical data to enhance workflow efficiency.
- Compiled data (comprehensive review) to enter necessary information into appropriate databases.
- Performed Data validation, accuracy checking, Database Reconciliation to ensure data integrity.
- SAE reconciliation
- Different Vendor Reconciliation including PK-PD, Lab data, Imaging Data
- Post Queries to ensure the accuracy and to obtain correct reaponse and communicate between cross functional teams for resolution.
- Performed data validation tasks (as per SOPs) to ensure accuracy and completeness of clinical trial data.
Clinical Data Specialist
IQVIA
Kolkata
10.2021 - 05.2023
- Performing Query Management, Vendor reconciliation, SAE reconciliation, NON ADMS checks, Manual listing review and Listings Review
- Understand, provide input to and comply with all applicable sections of Data Management Plan
- Resolve data clarifications, as directed by the Data Operations Coordinator
- Conduct basic quality control procedures
- Understand and comply with core operating procedures and working instructions
- Escalate problems to the attention of the Data Operations Coordinator or Group Manager
- Develop and maintain good communications and working relationships with CDM team.
Data Analyst (Project Data Manager)
Cognizant Technology Solution
08.2016 - 10.2021
- Represent Clinical Data Management at cross-functional forums, meetings and provide timely feedback to Vendors and site
- Authorizes the GoLive based on a review of completion of all activities for Clinical trials
- Handled data collection, ensuring accuracy and consistency of clinical data, and reviewing processes to ensure compliance with internal and external guidelines
- Supervised and instructed data management specialist and data entry personnel
- Performed validation & assisted with database QC and all data cleaning activities for all on-going and start-up studies with little supervision.
Education
Bachelor of Pharmacy - Pharmaceutical Engineering
Bengal School Of Technology
06-2016
Skills
- Clinical data Management
- Trial Data Analysis
- Expert in MS WORD, MS excel and Powerpoint
- Expert in software like, Spotfire, Medidata, Citrix, Rave X, DART tool
- Jarvis
- Inform database
- Data reconciliation and validation
- SAE reconciliation
Languages
- English, Full Professional Proficiency
- Hindi, Full Professional Proficiency
- Bengali, Native or Bilingual Proficiency
Projects
Handles studies from therapeutic areas like Oncology, Neurology, Antiviral and General Medicines, 12/2016, Present, Performed date review, validation, query development and resolution., Prepared and maintained DMP (Data Management Plan) and project status reports., Projected delivery responsibility; meeting timelines and deliverables of the projects., Resolved data discrepancy and related issues by interacting directly with investigator sites
Timeline
Senior Clinical Data Specialist
FORTREA Drug Development
05.2023 - Current
Clinical Data Specialist
IQVIA
10.2021 - 05.2023
Data Analyst (Project Data Manager)
Cognizant Technology Solution
08.2016 - 10.2021
Bachelor of Pharmacy - Pharmaceutical Engineering
Bengal School Of Technology
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