Mansi Shah
Clinical Trial Disclosure Senior Associate @AbbVie
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WORK HISTORY
Clinical Trial Disclosure Senior Associate @AbbVie
Led the preparation, submission, and maintenance of clinical trial registration and results disclosures on global public registries such as ClinicalTrials.gov, EudraCT) ensuring compliance with regulatory standards and timelines.• Reviewed complex clinical protocols, statistical analysis plans, ICFs, RFIs and other documents to redact CCI and PPD information.• Hosted training sessions for CTD team members and SMEs to stay aligned with regulatory requirements with FDA, EMA policy 0070 and other health authorities.• Collaborated with cross-functional teams (clinical operations, regulatory affairs, data disclosure team, medical writer, legal) to ensure accurate, timely, and consistent trial data disclosure.• Monitored and managed process of clinical trial disclosure, including tracking submission timelines, assigning studies and maintaining Excel sheet.• Developed and improved SOPs and processes to enhance disclosure compliance, efficiency, and accuracy.• Conducted QC reviews on registry submissions, ensuring the accuracy and completeness of data prior to public release.
EDUCATION
Kean University
Biology, Cellular and Molecular Biology
Fairleigh Dickinson University
Doctor of Pharmacy - PharmD, Pharmacy
ABOUT MANSI SHAH
As a dedicated PharmD graduate with a robust academic background and extensive experience…
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