sushma Sush
@sushmasush
Clinical data professional specializing in regulatory-compliant trial documentation.
What I'm looking for
I am a Master of Science in Organic Chemistry, Gold Medalist and university rank holder, with hands-on experience in clinical research operations and regulatory documentation.
In my recent role as Clinical Data Associate I managed CTMS updates, supported clinical data migration, and validated large-scale trial datasets aligned with CDISC and FDA submission standards.
Previously, as a Clinical Research Associate, I ensured GCP-aligned documentation for IRB and sponsor communications, supported protocol review, and helped prepare regulatory files across oncology and infectious disease studies.
I bring strong analytical reasoning, project management, and regulatory writing skills, and I am committed to contributing to organizations that advance patient outcomes through scientific and regulatory excellence.
Experience
Work history, roles, and key accomplishments
Clinical Data Associate
PointCross Lifescience
Sep 2024 - Present (1 year 1 month)
Managed CTMS updates and supported clinical trial data migration, validating large-scale datasets aligned with CDISC and FDA submission standards and contributing to oncology and infectious disease documentation.
Clinical Research Associate
Advarra Research Institute
Jun 2023 - Dec 2023 (6 months)
Ensured GCP-aligned documentation for IRB and sponsor communications, supported protocol review and regulatory file preparation for clinical operations.
Content Analyst
Insights IAS
Feb 2022 - May 2023 (1 year 3 months)
Designed analytical and reasoning content for UPSC-CSAT aspirants and conducted evaluations, showcasing regulatory writing, data review, and structured writing skills.
Education
Degrees, certifications, and relevant coursework
Unknown (institution not provided)
Master of Science, Organic Chemistry
Grade: Gold Medalist, University Rank Holder
Master of Science in Organic Chemistry; graduated as Gold Medalist and University Rank Holder.
Unknown (institution not provided)
Bachelor of Science, Botany; Zoology; Chemistry
Grade: University Topper
Bachelor of Science with majors in Botany, Zoology, and Chemistry; recognized as University Topper.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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