Harmanjot Kaur Gill
Clinical Data Analyst I
Banga
Summary
Clinical Data Analyst with over 2 years of experience in Clinical Data Management. Proven expertise in all phases of clinical studies, including setup, conduct, and lock phases. Skilled in data cleaning, testing, review, and freezing activities to ensure high-quality data integrity. Adept at identifying discrepancies, implementing solutions, and maintaining compliance with regulatory standards. Seeking to leverage my skills and experience to contribute to impactful healthcare solutions in a dynamic team environment.
Overview
3
3
years of professional experience
2022
2022
years of post-secondary education
2
2
Certifications
3
3
Languages
Work History
Clinical Data Analyst
Parexel International Pvt. Ltd.
11.2022 - Current
- Manage data cleaning and validation processes to ensure high-quality clinical data, ensuring compliance with study protocols and regulatory guidelines.
- Perform data review & freeze activities to ensure data integrity before database lock.
- Oversee listings review (Offline, PD, SAE) and vendor reconciliation to ensure consistency and accuracy across multiple sources.
- Lead the creation and management of reconciliation trackers (Vendor and SAE trackers), ensuring timely issue resolution and data consistency.
- Coordinate MR listings, queries, and MM trackers to support ongoing clinical trials and ensure data completeness.
- Develop and test mock shell creations; write test cases and perform UAT to ensure system functionality and data accuracy.
- Create and manage SOPs (Protocol, CCIs, DVS, ALS) to ensure standardized operating procedures in clinical data management processes.
- Handle SAE tool management and support DURFs to track adverse events and deviations, ensuring regulatory compliance.
- Utilize EDC systems including Medidata Rave, Calyx EDC/Data Labs, Jira, and Idarts for efficient data collection, reporting, and issue tracking.
Education
Master's - Pharmacy Practice
Punjabi University
Bachelor's - Pharmacy
Rayat Bahra University
Skills
- Data Cleaning & Validation
- Data Review & Freeze
- Listings Review (Offline, PD, SAE, Vendor Reconciliation)
- Reconciliation Trackers (Vendor and SAE Trackers)
- MR Listings & Queries, MM Tracker
- Mock Shell Creation & UAT (Test Case Writing and Testing)
- SOPs (Protocol, CCIs, DVS, ALS)
- Status of Reports (ACPT)
- SAE Tool & DURFs
- EDC Systems: Medidata Rave, Calyx EDC/Data Labs, Jira, Idarts
Certification
iMedidata Rave and Rave X
Timeline
Clinical Data Analyst
Parexel International Pvt. Ltd.
11.2022 - Current
Bachelor's - Pharmacy
Rayat Bahra University
Master's - Pharmacy Practice
Punjabi University
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