Shivam Mahajan
Records Management @IQVIA
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WORK HISTORY
Records Management @IQVIA
Thane, IN
EDUCATION
College of Pharmacy, IPS Academy, Rajendra Nagar, A.B. Road, Indore-452012
Bachelor of Pharmacy - BPharm
ABOUT SHIVAM MAHAJAN
Experienced in the meticulous filing of essential documents such as IB, Clinical Trial Protocols, and Informed Consents into TMF, adhering strictly to reference models. Diligent in quality checks, ensuring documents meet ALCOA+ guidelines for attributability, legibility, and accuracy. Skilled in creating seamless TMF delivery processes and maintaining audit-ready eTMF. Proficient in client interaction, providing robust workaround solutions promptly. Versatile in filing clinical documents at site, country, and study levels, ensuring TMF health for assigned studies. Adept at performing eTMF reconciliation tasks and resolving discrepancies efficiently. Effective in editing clinical documents for language, grammar, and technical accuracy. Experienced in distributing records to specific sites and categorizing documents appropriately. Committed to ensuring TMF completeness, conducting reviews, and resolving issues promptly. Proficient in optimizing existing TMF systems and contributing to performance improvements. Skilled in mapping clinical documents to DIA reference modules and creating draft placeholders from study frameworks. With a focus on accuracy and efficiency, I play a vital role in releasing error-free documents for regulatory submissions.
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