Skills
TECHNICAL SKILLS
Clinical Trial Platforms: Medidata RAVE, iMedidata, CTMS, Veeva Vault
Pharmacovigilance Systems: Argus Safety, Risk Management Tools
Data & Statistical Analysis: EDC, TLF, SDV, Clinical Data Review
Regulatory & Compliance: ICH-GCP, FDA, EMA, 21 CFR Part 11
CERTIFICATIONS & PROFESSIONAL AFFILIATIONS
Certified Clinical Research Professional (CCRP)
Good Clinical Practice (GCP) Certified
Member, Drug Information Association (DIA)
Member, American Society of Clinical Oncology (ASCO)
About
Dedicated and results-driven Clinical Consultant with over 8 years of experience in clinical research, drug safety, Pharmacovigilance , and medical monitoring. Expertise in data review, protocol development, regulatory compliance, and scientific strategy in various therapeutic areas, including Oncology, CNS, Orphan Drugs, Dermatology, Infectious Diseases, and Hematology. Adept at providing strategic guidance, regulatory insights, and data-driven decision-making to optimize clinical trial outcomes and ensure compliance with industry standards.
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