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sushma Sush

@sushmasush

Clinical data professional specializing in regulatory-compliant trial documentation.

India
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What I'm looking for

I seek a role in clinical data or regulatory operations where I can apply CTMS, CDISC, and GCP expertise, contribute to high-quality submissions, and grow in a collaborative, patient-focused research environment.

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

AI

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.

Education

Degrees, certifications, and relevant coursework

UP

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.

UP

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

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