Mridula Nandre
Senior Document Review Specialist , Regulatory & Patient Document Solutions (RPDS), Global Medical Writing Clinical Research
- Role
- Senior Document Review Specialist (Rpds Global Medical Writing Clinical Research) at Ppd
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
Research & DevelopmentView LinkedIn profile
About Mridula Nandre
Healthcare and Clinical Research Professional with 13 years of diverse experience…
Experience
Senior Document Review Specialist (Rpds Global Medical Writing Clinical Research)
Dec 2024 — Present
Skills
- Clinical Trial Management
- Fda, Cioms , Ctcae,Intralinks Online Safety Reporting Notification System
- Interactive Web Response System (Iwrs)
- Clinical Trials
- Ae , Sae
- Sas Pheedit Version 3
- Clinical Research
- Iata,Higher-Quality Data
- Irb
- Cardiology
- Cancer
- Gcp
- Ich-Gcp
- Patient Recruitment
- The Belmont Report,Declaration of Helsinki ,Code of Federal Regulations
- Clinical Monitoring
- Informed Consent
- Ecrf’s Inform, Oracle Clinical Remote Data Capture, Medi Data Rave
- Recist Criteria 1.0 & 1.1, Ecog
- Safety Reporting Noification System( Safrns) & Intralink
- Ctms
- Pro- Eortc Qlq-C 30, Eq -5d
- Oncology
- Protocol
- Sop
- Fda
- Time Management
- Ability to Set and Meet Deadlines with High Quality Work
- E Systems -Interactive Voice Response System (Ivrs)
- Ich-Gcp, Schedule Y, Protocol, Informed Consent Form,
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