Hi, I’m
Paragi Patel
Scarborough,ON
Summary
Experienced Clinical Data Associate with 7 years in clinical data management. Proficient in EDC systems, data verification, and report generation. Skilled in maintaining documentation, ensuring regulatory compliance, and collaborating with cross-functional teams. Known for strong problem-solving abilities, attention to detail, and effective multitasking. Seeking to apply extensive data management skills to a dynamic clinical research environment.
Overview
7
years of professional experience
Work History
Life Labs
Clinical Data Associate
01.2020 - Current
Job overview
- Assisted in Developing Safety Data Review Plans: Supported the creation and updating of safety data review plans for clinical trials, focusing on laboratory data, adverse events (AEs), serious adverse events (SAEs), and other key safety metrics.
- Performed Safety Data Reviews: Conducted safety data reviews as per established plans, identifying potential issues in AEs, SAEs, and medical events of special interest. Escalated findings to senior team members for resolution.
- Collaborated with Data Management Teams: Worked alongside Clinical Data Managers and Project Managers to help maintain the quality and accuracy of clinical trial data. Documented and reported discrepancies to ensure timely resolution.
- Assisted with Medical Coding: Provided support in coding AEs, medical histories, and medications using MedDRA and WHO Drug dictionaries, contributing to consistent data collection and analysis.
- Supported CRF Review and Protocol Processes: Assisted in reviewing Case Report Forms (CRFs) and trial protocols, contributing to the accuracy and consistency of laboratory data collection processes.
- Maintained Laboratory Data Accuracy: Coordinated with Clinical Data Managers to verify the accuracy of laboratory data, ensuring alignment with standard review checklists and protocols.
- Participated in Data Management Projects: Contributed to Clinical Data Management projects, providing assistance in areas such as data verification, and ensuring compliance with established standards.
Sharda Hospital
Clinical Data Coordinator
05.2017 - 08.2019
Job overview
- Data Entry and Verification: Entered and verified clinical trial data in electronic data capture (EDC) systems, ensuring accuracy and adherence to study protocols.
- Monitored and Cleaned Data: Conducted preliminary reviews and supported data cleaning activities by identifying discrepancies and working with clinical sites to resolve issues.
- Maintained Study Documentation: Organized and managed clinical trial master files, including Case Report Forms (CRFs) and electronic CRFs (eCRFs), ensuring timely and accurate data entry and documentation.
- Generated Reports and Listings: Assisted in generating data listings, summary reports, and data queries for review by senior data managers and project teams.
- Collaborated with Clinical Teams: Worked closely with clinical research associates, data managers, and clinical sites to ensure smooth data flow, consistency, and adherence to study timelines.
- Supported Database Management: Assisted in the setup, testing, and maintenance of clinical trial databases, contributing to the efficient management and integrity of study data.
- Ensured Regulatory Compliance: Supported the preparation of data for regulatory submissions, ensuring all documentation met compliance standards and followed SOPs, Good Clinical Practice (GCP), and applicable guidelines.
Education
CHARUSAT UniversityVallabh Vidhyanagar, Gujarat, India
Master of Science from Microbiology
01.2019
SP UniversityVallabh Vidhyanagar, Gujarat, India
Bachelor of Science from Microbiology
01.2015
Skills
- Electronic Data Capture (EDC) Systems
- Data Quality Assurance
- Clinical Documentation Management
- Data Cleaning and Verification
- Report Generation
- Regulatory Documentation Preparation
- Interdepartmental Communication
- Time Management
- Problem-Solving
- Collaboration and Teamwork
- Database Management Support
- Training and Onboarding Support
- Adaptability
- Attention to Detail
- Regulatory Compliance
- Data Analysis Support
Languages
English
Full Professional
Timeline
Clinical Data Associate
Life Labs
01.2020 - Current
Clinical Data Coordinator
Sharda Hospital
05.2017 - 08.2019
CHARUSAT University
Master of Science from Microbiology
SP University
Bachelor of Science from Microbiology
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