Sharada Marathe
Statistical Programmer | Clinical Research Specialist | Expertise in ICH GCP E6(R2)
- Role
- Clinical Research Trainee at Clinical Research Fastrack
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Sharada Marathe
My journey in the pharmaceutical industry, currently as a trainee with Clinical Research Fastrack, has deepened my expertise in data management and clinical trial operations. With a strong foundation in statistical programming, I am focused on maintaining the integrity and compliance of clinical research data in alignment with ICH GCP E6 (R2) and FDA regulations. My experience includes CDISC compliance, e-submissions, and query resolution, which now support my oversight of clinical trial protocols. With expertise in SDTM dataset development and a thorough understanding of the data lifecycle, from feasibility to close-out, I ensure precision and quality in regulatory documentation and trial operations
Experience
Clinical Research Trainee
Sep 2024 — Present · San Francisco, CA, US
ICH GCP E6 R (2) FDA Regulations 21CFR 11, 50, 54, 56 and the Common Rule 45 CFR 46 Data Management Informed Consent Process Clinical Trial Operations from feasibility through close-out GDP following ALCOA-C principles Identification and reporting of AEs and SAEs Quality Assurance, Monitoring, and Query Resolution Comprehension and Execution of Clinical Trial Protocols Maintaining a regulatory binder, housing essential documents including but not limited to 1572,DOA, Training Logs, and other Investigator Site File (ISF) documents.
Education
Rajiv Gandhi Institute of IT and Biotechnology, Bharati Vidyapeeth, Pune.
Master of Science (MSc)
2013 — 2015
UC Berkeley Extension
Certificate Program in Clinical Research Conduct and Management
2024 — 2024
University of Pune
Bachelor of Science (BSc)
2010 — 2013
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