Manoj Patel

Senior Medical Writer & Clinical Research Specialist with 13+ years of experience in regulatory documentation, TMF/eTMF management, and pharmacy operations. Skilled in bilingual medical writing (English, Gujarati, Hindi), compliance, and transforming complex data into clear, impactful communication

• 13+ years in clinical research, medical writing, and pharmacy operations, delivering regulatory-compliant documentation across CROs and hospitals.
• Expertise in protocols, informed consent forms, subject diaries, TMF/eTMF management, and SOP revision, ensuring clarity and compliance with GCP/NDCT rules.
• Strong background in pharmacy operations—dispensing, inventory management, ADR reporting, and NABH compliance—supporting patient safety and audit readiness.
• Skilled in cross-functional coordination with investigators, sponsors, CROs, and translation agencies, including bilingual medical writing (English, Gujarati, Hindi).
• Experienced in mentoring and training new professionals, leading QA/QC reviews, and managing culturally appropriate translations of study materials.

Pharmacy graduate with advanced training in clinical research management and continuous certification in GCP/NDCT rules, combining scientific knowledge with regulatory expertise.