SAMPRITI TEWARI
Data Management
Durgapur
Summary
- To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
- Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
- Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
5
5
years of professional experience
19
19
years of post-secondary education
3
3
Languages
Work History
Senior Clinical Data Coordinator
ICON Plc
7 2023 - Current
- Query management
- SAS Listings review
- Manual Listings review
- SAE reconciliation Via SARA application
- Vendor reconciliation
- Medical validation listings review
- Status report and CPT
- SAS listings validation
- Edit checks AT testing Via ARMADA application
- POC for 1 study (Focusing on Pulmonary Exacerbation under Sanofi Portfolio)
- Management of Teams
- Patients Profile generation and review
- Clinical Case Review
- AEDR review
Clinical Data Specialist
IQVIA
07.2019 - 06.2023
- Query management
- SAS Listings review
- Manual Listings review
- Performed manual SAE reconciliation
- Performed manual Vendor reconciliation
- Bios Review
- Status report and CPT (Preparation)
- Backup DOC for 2 studies (Focusing on Oncology and Pulmonary exacerbation)
- Performed manual Local lab reconciliation
- Dataset QC/ Data transfer (Structural and One subject Validation)
- SAS listings validation 9From specs to validations)
- DOC for 3 studies (Focusing on Cystic Fibrosis, Pulmonary exacerbation & Oncology)
- Management of Teams (Trained junior)
- PRCF raising and validating for SAS listings issues and customs reports
- Documents preparation (Edit checks specs)
- Validation of custom reports (SAE audit trail report, Missing pages report)
Cord Blood Bank Technician (QC Officer)
Cordlife Sciences India Pvt. Ltd.
9 2018 - 2 2019
- Assisted in training new technicians, improving overall team performance and knowledge sharing.
- Streamlined the donation process for a better donor experience and increased successful donations.
- Reduced cross-contamination risks by adhering to stringent sterilization protocols for equipment and workspaces.
- Conducted regular equipment maintenance checks, resulting in consistent accuracy and minimal downtime.
- Adhered to strict labeling practices to guarantee proper identification and traceability of all collected samples throughout the testing process.
- Followed strict confidentiality policies to protect patient privacy while managing sensitive records and data.
- Followed Good Laboratory Practices (GLP) consistently across daily activities and special products.
- Troubleshot problems with equipment and recalibrated devices or brought serious concerns to supervisor for handling.
- Preparation of IQ, OQ & PQ of the new instrumentation
- Calibration & Maintenance of the laboratory instruments with maintaining of relevant documents
- Quality checking and approval of the consumables as per SOP
- Maintaining of Equipment/ Instrument Failure Report, Equipment Master List & Quality Record
Education
BITS – Biocon Certificate Program in Microbiology - Microbiology
Biocon Academy
Bengaluru 04.2001 -
Master of Science - Biochemistry
Oriental Institute of Science & Technology
Bardhaman, India 06.2016 - 06.2018
Bachelor of Science - Chemistry
Durgapur Government College
Durgapur, India 07.2012 - 07.2015
Class XII - Science
SKS Public School
Asansol, India 07.2010 - 05.2012
Class X - Science
ST. Peter's School
Durgapur, India 04.1998 - 05.2010
Skills
Adaptability and Flexibility
Test script writing
Problem-Solving
Teamwork and Collaboration
User Acceptance Testing
Active Listening
Problem-solving aptitude
Clinical trial protocols
Data Cleaning
Clinical Data Management
Data Validation
SOP compliance
Continuous Improvement
Task Prioritization
Team Collaboration
Data Quality Assurance
Electronic Data Capture
Clinical Research
Data Reconciliation
Data management expertise
Conflict resolution techniques
Decision-making capabilities
Clinical trial knowledge
Data Cleaning Methods
Course Deliverables
BITS- Biocon Certificate Programme in Applied Industrial Microbiology8 week full-time Certificate Program in Applied Industrial Microbiology, is designed to have classroom sessions to impart function specific knowledge as well as inculcate the application know how of various techniques used in microbiological analysis through industry assignments and functional training.Class room training is delivered by renowned Faculty from BITS and Biocon AcademyHands on 1 week training at Biozeen to provide practical experience.Course DeliverablesKnowledge of working in a clean room and Laminar air flowEnvironmental monitoringBioburden testingEndotoxin testingSterility testingIdentification of micro-organisms (VITEK 2 compact system)
Projects
Comparative studies of antibiotic potential and enzymes activity of different vegetables peel, Oriental Institute of Sciences and Technology, 01/2018, 03/2018, To determine antibiotic effect of different extracts of different vegetables peel, Preparation of samples, Preparation of extracts, Phytochemical Screening, Antibiotic activity by agar well diffusion assay, To determine enzyme activity of different vegetables peel, Fermentation for a period of 30 days, Activity measured at 540 nm using spectrophotometer
Timeline
Clinical Data Specialist
IQVIA
07.2019 - 06.2023
Master of Science - Biochemistry
Oriental Institute of Science & Technology
06.2016 - 06.2018
Bachelor of Science - Chemistry
Durgapur Government College
07.2012 - 07.2015
Class XII - Science
SKS Public School
07.2010 - 05.2012
BITS – Biocon Certificate Program in Microbiology - Microbiology
Biocon Academy
04.2001 -
Class X - Science
ST. Peter's School
04.1998 - 05.2010
Senior Clinical Data Coordinator
ICON Plc
7 2023 - Current
Cord Blood Bank Technician (QC Officer)
Cordlife Sciences India Pvt. Ltd.
9 2018 - 2 2019