DIVYASREE BABU
TMF | Records Management Analyst @IQVIA | UAT | B. Tech in Biotechnology and Biochemical Engineering at Iqvia India
Based in Kerala, India
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Seniority
Other
Department
Other
Location
Kerala
Industry
Hospitals and Health Care
Company size
6.2K
Contact information
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d•••••••@iqvia.com
Phone
5 credits+91 ••• •••• ••••
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Background
About DIVYASREE BABU
As a challenge driven eTMF Document Specialist with a passion for clinical research I thrive on ensuring the highest standards of document management. My expertise lies in maintaining inspection-ready eTMFs adhering to ICH-GCP guidelines and collaborating with cross-functional teams. Key Strengths: eTMF Management: Proficient in overseeing the day-to-day operations of eTMFs including document indexing QC document review approve list change migration projects remediation and reporting. Regulatory Compliance: Solid understanding of ICH-GCP guidelines and regulatory requirements related to clinical document management. Quality Assurance: Diligently ensure that clinical trial documentation aligns with eTMF specifications and SOPs. Problem-Solving: Skilled at identifying trends addressing questions and providing best practice recommendations. Collaboration: Thrive in cross-functional environments fostering strong relationships with stakeholders. Mission: My mission is to contribute to groundbreaking studies by maintaining impeccable eTMFs and supporting clinical trial excellence. Let’s Connect: Feel free to reach out to me via LinkedIn or email: divyasreebabu@gmail.com
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