Radhakumari Rai
@radhakumarirai
I maintain inspection-ready eTMF documentation for global clinical trials.
IndiaWhat I'm looking for
At IQVIA, I maintain inspection-ready eTMF documentation in Veeva Vault for global clinical studies. I review, index, validate metadata, manage versions, and resolve document discrepancies in line with sponsor SOPs and regulatory standards.
Previously at Citius Clinical Research Services, I coordinated Phase III and IV investigator-site activities across seven therapeutic areas. I supported TMF and ISF reviews, SDV, CRF and query management, SAE/AE reporting, regulatory documentation, and site communications.
I've supported 5+ Phase III/IV trials while maintaining protocol and ICH-GCP compliance. I bring hands-on experience with audit readiness, UAT, clinical trackers, and cross-functional document management.
Experience
Work history, roles, and key accomplishments
Reviewed and indexed essential and non-essential TMF documents in Veeva Vault eTMF, ensuring accurate filing per sponsor SOPs and regulatory standards. Maintained quality standards, tracked deviations, and supported audit readiness and UAT.
Clinical Research Coordinator
Citius Clinical Research Services
Nov 2023 - Dec 2024 (1 year 1 month)
Coordinated Phase III and IV trials across seven therapeutic areas, managing site activities, TMF/ISF file review, SDV, and CRF data entry. Ensured protocol and ICH-GCP compliance, supported SAE/AE reporting, and maintained clinical tracking databases.
Clinical Research Intern
Ingenious Healthcare
Jun 2023 - Oct 2023 (4 months)
Assisted with maintenance of clinical and regulatory documents, supported filing and retrieval of CRFs and DCFs in eCTD-compliant processing. Gained foundational knowledge of GCP, GDP, and clinical data management.
Education
Degrees, certifications, and relevant coursework
Lifepoint Research Centre
Workshop, Clinical Data Management
2023 - 2023
Attended a Clinical Data Management Workshop.
Ingenious Healthcare Organization
Certification Course in Clinical Research and Pharmacovigilance, Clinical Research
2023 - 2023
Completed a certification course in Clinical Research and Pharmacovigilance.
Indrayani Institute of Pharmaceutical Education and Research
Bachelor of Pharmacy, Pharmacy
2019 - 2023
Grade: 8.03/10
Bachelor of Pharmacy (B.Pharm) degree with a CGPA of 8.03/10.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Social media
Job categories
Skills
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