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Ishaan Nair
Clinical Research/TMF Lead
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.
FORMERLY AT
Parexel International
LOCATION
Hyderabad
AVAILABILITY
Full Time
Skills
Audit Prep
CTMS
Document Management
Document Tracking
eTMF Systems
Metadata Standards
Metrics Reporting
MS Office
Power BI
QC & Inspection Readiness
QC Logs
SOP-driven QC
TMF Oversight
TMF Plans & QC Tracking
TMF Review
+1 More
Work Experience
TMF Inspection Readiness Specialist
Parexel International (India) Pvt. Ltd.,
Apr 2019 - April 2024 – September 2024
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Create TMF plans, PQC logs, and EDL customization. Lead TMF review meetings, mentor reviewers, and ensure inspection readiness. Send automation, completeness, and in-progress reports to study teams and sponsors while reviewing study/site status in CTMS.
TECHNOLOGIES
Veeva Vault, CTMS, Power BI, MS Office, TMF Plans & QC Tracking
TMF Inspection Readiness Specialist
Parexel International (India) Pvt. Ltd.,
April 2024 – September 2024
- Led TMF plan design and resource assessment for study QC milestones.
- Coordinated vendor documentation and ensured client oversight of TMF deliverables.
- Mentored junior team members and drove best practice sharing across teams.
TECHNOLOGIES
Veeva Vault, TMF Oversight, QC & Inspection Readiness
