Rajni Shivpuje

I’m a Doctor of Pharmacy (Pharm. D postgraduate) with hands-on experience across clinical research operations, clinical data management, and pharmacovigilance. I’m CPC Certified(AAPC) and I bring a quality-first approach grounded in ICH-GCP E6 R2 and trial documentation discipline.

As a Clinical Research Coordinator (CliniWings), I coordinate Phase II–III trials with sponsors including Zydus, Lambda, and Raptim. I manage patient recruitment, consent, screening, enrollment, and follow-up while supporting end-to-end site execution through source documents, eCRF entries, query responses, and TMF/ISF maintenance.

In addition to site operations, I contribute to drug safety and medical safety services through pharmacovigilance activities and ADR reporting workflows. I’ve supported clinical monitoring readiness through participation in SQV/SSV/SIV and monitoring visits, and I understand how IP accountability and site operations connect to compliant study conduct.

I’m also expanding into Medical Writing and Regulatory Affairs through certifications and structured learning (including NABH accreditation documentation support). I’m motivated by roles where I can combine clinical research, CDM, PV, and documentation rigor to improve accuracy, patient experience, and study outcomes.