As the Centralized Trial Lead at IQVIA, my focus is on advancing clinical research by leveraging my Master's in Biotechnology from Punjab Technical University. I excel in site management, ensuring adherence to ICH-GCP guidelines, and driving patient enrollment through strategic vendor partnerships. My role entails a dynamic interplay between study management and maintaining regulatory compliance, where responsiveness and meticulous data review are key. Our team's commitment to enhancing study deliverables is manifested in the successful orchestration of trials and the deployment of risk-based monitoring techniques.Experience on Clinical modules of Regulatory reports NDA, BLA and safety reports of PBRER and DSUR.Oversight the work on various steps of Annual reporting. Perform Management monitoring Quality Check.Experienced Clinical Research Professional with three years in Regulatory start up activities and three years in regulatory project management. As a CML, had experience in the Site contracts end to end process ,IP label preparation, Sponsor Contract Management system and contact and research facility creation in CTMS. Expertise in Clinical Trial Management System, eTMF tool, Clinical Trial Agreements, Confidential Disclosure Agreements, Essential Document pack. As a CML, handled regulatory project management activities such as tracking the quality of the deliverables in all the phases of the project.
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Centrailized Monitoring LeadIqviaIndia -
Centrailized Trial LeadIqvia Nov 2022 - PresentMumbai, Maharashtra, IndiaWorking in Clinical research domain -
Senior Clinical Site AssociateIqvia Jun 2021 - Oct 2022Mumbai, Maharashtra, IndiaIn-House CRA, ICH- GCP trained, Vendor Management, Site Communication, Site Management, Study Management, -
Clinical Site Associate IIqvia May 2019 - May 2021Mumbai, Maharashtra, IndiaIn-house CRA, Data Review, Site Management, ICH-GCP Trained, Document Management, -
Clinical Research CoordinatorPpd Apr 2016 - May 2019Mumbai Metropolitan Region
Anu Rai Education Details
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Biotechnology -
Biotechnology -
St Joseph Convent School VaranasiHsc -
St Joseph Convent School VaranasiSsc
Frequently Asked Questions about Anu Rai
What company does Anu Rai work for?
Anu Rai works for Iqvia
What is Anu Rai's role at the current company?
Anu Rai's current role is Centrailized Monitoring Lead.
What schools did Anu Rai attend?
Anu Rai attended Punjab Technical University, Punjab Technical University, Punjab Technical University, Veer Bahadur Singh Purvanchal University, Jaunpur, St Joseph Convent School Varanasi, St Joseph Convent School Varanasi.
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