Hire Talented Document / Data QC Specialists

MES Lead Consultant

kshaya Kumar is an MES Lead Consultant with over 8 years of experience in pharmaceutical manufacturing systems. He specializes in MES design, implementation, and integration across Syncade, Werum PAS-X, and DeltaV platforms. Skilled in GxP compliance, recipe authoring, and end-to-end MES lifecycle management, Akshaya has led cross-functional teams on global projects for clients like Bristol Myers Squibb, Lonza, Genentech, and Novo Nordisk. His expertise includes SAP, LIMS, and DCS integrations, technical documentation, and GMP validation under FDA and GAMP 5 standards.

TMF Lead

Ishaan Nair is a Clinical Research/TMF Lead with 10+ years of experience in TMF management, inspection readiness, and clinical documentation. He has led TMF oversight across multiple global studies, ensuring compliance with ICH-GCP, audit standards, and sponsor requirements. Skilled in TMF planning, QC, milestones tracking, CTMS review, and team mentoring, Ishaan collaborates with cross-functional study teams to maintain audit-ready documentation throughout the trial lifecycle.

Clinical Operations

Kabir Kapoor is a clinical operations professional with 11+ years of experience in Trial Master File (TMF) management and Quality Management Systems. He has led TMF strategy and execution for 70+ global studies across Phases I–IV, ensuring regulatory compliance, inspection readiness, and process optimization. Skilled in Veeva Vault, CAPA management, CRO oversight, and enterprise-level TMF standardization, Kabir partners with cross-functional stakeholders to drive audit-ready documentation and operational excellence.

Clinical Research Documentation/TMF Specialist

Rohan Chakraborty is a Clinical Research Documentation/TMF Specialist with experience in records management, document QC, and audit readiness across global clinical studies. Skilled in eTMF systems, metadata management, and compliance review, he supports inspection preparedness and collaborates with study teams to ensure accurate, complete, and audit-ready trial documentation.

Clinical Research

Samar Patel is a Clinical Research professional with 7+ years of experience specializing in Trial Master File (TMF) management, inspection readiness, and archiving operations across global clinical studies. He has led TMF oversight, compliance reviews, and automation-driven process improvements, ensuring complete and audit-ready documentation in alignment with ICH-GCP and regulatory standards.