Manish Kinkar
Trail Master File Reviewer @Tata Consultancy Services
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WORK HISTORY
Trail Master File Reviewer @Tata Consultancy Services
Mumbai, IN
Clinical Operations professional with 1.5 years of experience in eTMF management using Veeva Vault Clinical, experienced in document uploading, indexing, and QC review in compliance with ICH-GCP and TMF Reference Model. eTMF Management• Veeva Vault Clinical (TMF)• TMF Reference Model• Clinical Trial Documentation• QC Review• Document Indexing• Metadata Management• ICH-GCP Compliance• ALCOA+ Principles• Clinical Operations• Inspection Ready TMF• Regulatory Documentation• SOP Compliance• eTMF Reporting• Clinical Trial Support
EDUCATION
Priyadarshini J. L. College of Pharmacy
Master of Pharmacy , Pharamceutics
Priyadarshini J L college of Pharmacy
Bachelor of Pharmacy , Pharmacy
ABOUT MANISH KINKAR
Clinical Operations professional with 1.5 years of experience in eTMF management using Veeva Vault Clinical, experienced in document uploading, indexing, and QC review in compliance with ICH-GCP and TMF Reference Model.• eTMF Management• Veeva Vault Clinical (TMF)• TMF Reference Model• Clinical Trial Documentation• QC Reviewing and uploading trail doc.• Document Indexing• Metadata Management• ICH-GCP Compliance• ALCOA+ Principles• Inspection Ready TMF• Regulatory Documentation• SOP Compliance• eTMF Reports Handling• Clinical Trial Support-Additionally, I have 6 months of experience as a Safety Science Analyst in pharmacovigilance, with hands-on exposure to ArisG, Ag Exchange, and MedDRA-Motivated pharmacy master\'s graduate- Strong academic foundation, passionate about pharmaceutical excellence- Expertise in- Pharmacovigilance - Clinical Research - Regulatory Affairs - Clinical data management - Quality Assurance- Analytical skills, compliance knowledge, and attention to detail for ensuring drug safety and regulatory compliance- Proactive problem-solving approach, dedicated to maintaining the highest industry standards- Thrives in collaborative environments, excelling in effective communication to drive results- Eager to contribute expertise to a dynamic team- Seeking connections to explore mutual success opportunities-#PharmaProfessional #Healthcareprofessional #Pharmacovigilance #clinicaloperation #eTMF specialist #DrugSafetyassociate#ClinicalResearch #RegulatoryAffairs #QualityAssurance
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