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Nidhi Nayan

@nidhinayan

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Senior Clinical Data Analyst at Fortrea managing clinical trial data quality, cleaning, and study close-out.

India

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What I'm looking for

I’m looking to contribute my knowledge and personal strengths to a dynamic, growth-oriented organization, with exposure to a competitive environment and challenging responsibilities.

At Fortrea Development India Private Limited, I work as a Sr. Clinical Data Analyst across clinical study setup, maintenance, and close-out. I help ensure data quality and timely delivery of clinical data management work.

I perform data cleaning, discrepancy management, and query resolution, and conduct User Acceptance Testing for data entry screens and review listings. My work also includes data validation and Serious Adverse Event reconciliations.

Across studies from Phase I to Phase III, I’ve worked in therapeutic areas including cardiovascular disease, infectious disease, immunology, respiratory disease, neurology, and oncology. I use EDC systems including Veeva vault, Zelta, and Medidata Rave, with knowledge of Good Clinical Practice.

Before Fortrea, I worked as a Clinical Data Coordinator at IQVIA, reviewing clinical trial data and supporting vendor data reconciliation. Earlier, I worked as a lab technician at Narayana Hrudayalaya, Sagar Hospital, and Mallya Hospital.

Experience

Work history, roles, and key accomplishments

Current

Sr. Clinical Data Analyst

Current

Fortrea Development India Private Limited

Mar 2018 - Present (8 years 8 months)

Primary point of contact for day-to-day activities on assigned clinical studies, overseeing study set-up, maintenance, and close-out tasks. Accountable for ensuring high data quality and timeliness of CDM deliverables, including developing data management documentation and performing UAT.

Clinical Data Management EDC Veeva Vault Zelta Medidata EDC User Acceptance Testing Data Cleaning SAE Reconciliation GCP Team Management Vendor Management

Clinical Data Coordinator

IQVIA

Mar 2016 - Feb 2018 (1 year 11 months)

Reviewed clinical trials data in accordance with Data Management Plans and standardized processes to identify erroneous, missing, or implausible data. Generated, resolved, and tracked queries, and applied quality control procedures to ensure data quality standards.

Clinical Data Management data review Query Management Quality Control Data Reconciliation EDC