kavya shankar
@kavyashankar
Detail-oriented clinical research professional with regulatory expertise.
What I'm looking for
I am a detail-oriented clinical research professional with a robust background in regulatory coordination, essential document management, and effective site communication. My experience spans across various roles in clinical research, where I have honed my skills in ensuring compliance with both global and local regulations. I thrive in collaborative environments, working closely with cross-functional teams to drive study startup activities and meet project timelines.
At IQVIA, I excelled as a Regulatory Coordinator - Startup Specialist, where I managed essential regulatory documents, coordinated ICF handling, and ensured timely regulatory submissions. My proactive approach to project support and communication has enabled me to maintain high standards of quality oversight and audit readiness. Previously, at Koncord Clinical Research, I oversaw the preparation of submission documents for regulatory authorities, ensuring accuracy and compliance throughout the study lifecycle.
With a Master's degree in Biotechnology and a Diploma in Clinical Research and Clinical Data Management, I am committed to leveraging my expertise to support the successful execution of clinical studies from start-up through close-out. I am eager to contribute to a dynamic team that values innovation and excellence in clinical research.
Experience
Work history, roles, and key accomplishments
Regulatory Coordinator - Startup Specialist
IQVIA
Mar 2025 - Present (5 months)
Reviewed, compiled, and organized essential regulatory documents and study files to ensure inspection readiness and alignment with global standards. Coordinated country-specific ICF versions based on affiliate feedback and tracked regulatory queries to ensure timely resolution and document alignment. Prepared and compiled country-level submission packages, ensuring documents met regulatory require
Regulatory Coordinator
Koncord Clinical Research
Apr 2024 - Mar 2025 (11 months)
Managed startup documents including 1572s, Protocols, Investigator Brochure, and Financial Disclosure Forms, tracking completion status and routing for appropriate signatures. Oversaw timely submission of initial protocols, amendments, and ICF versions to IRBs, tracking approval documents and maintaining organized study folders. Coordinated the preparation of country-level submission documents for
Quality Assurance Officer
Malladi Pharmaceuticals Pvt. LTD
May 2022 - Feb 2024 (1 year 9 months)
Ensured data accuracy and compliance through thorough reviews of quality assurance processes and adherence to industry standards. Managed GMP inspections, participated in regulatory audits, and ensured full compliance with regulatory standards. Collaborated with R&D, manufacturing, and regulatory teams to ensure seamless regulatory alignment.
Education
Degrees, certifications, and relevant coursework
Vellore Institute of Technology, Vellore
Masters in Biotechnology (Integrated), Biotechnology
2015 - 2020
Grade: 8.5
Completed an integrated Master's program in Biotechnology, gaining comprehensive knowledge in the field. Achieved a strong academic performance with a grade of 8.5.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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