F5 BioTalent Makes Hiring Easy
We handle the recruitment process, screening and shortlisting candidates.
Kiran Nath
Clinical Project Manager
Clinical Project Manager
Kiran Nath is a Clinical Project Manager with 9+ years of experience leading end-to-end clinical trial operations across India, APAC, and Africa. He specializes in global site oversight, risk mitigation, vendor coordination, and audit/inspection readiness under ICH-GCP and ISO 9001/13485/27001 frameworks. With expertise in CTMS, eTMF, EDC, and IVRS/IWRS systems, Kiran drives timelines, enrollment targets, and quality outcomes across multi-site trials.
FORMERLY AT
MakroCare
LOCATION
Hyderabad, India
AVAILABILITY
Full-time
Skills
Audit & QA Systems
CAPA Tracking
Central Monitoring Dashboards
CTMS
EDC
eTMF
ISO 9001/13485/27001 SOP Alignment
IVRS/IWRS
Protocol/Report Review
QA Documentation
SOP Deviation Tracking
Work Experience
Clinical Quality Assurance Manager
Croissance Clinical Research
December 2022 – October 2024
- Led clinical and vendor audits (routine & for-cause) ensuring global GCP and ISO compliance.
- Oversaw internal audit readiness for ISO 9001, 13485, and 27001 certifications.
- Reviewed SOPs, quality documents, CAPA activities, and supported protocol/CRF reviews.
- Performed site qualification, initiation, and close-out audits across India, Nepal, and Africa.
TECHNOLOGIES
ISO 9001/13485/27001 SOP Alignment, CAPA Tracking, Audit & QA Systems
Senior Clinical Research Associate
Axis Clinical
July 2017 – December 2022
- Managed monitoring, source data verification, and trial master file accuracy.
- Conducted internal/system/vendor audits per ICH-GCP.
- Managed audit findings and CAPA actions and ensured site/document readiness for database lock.
TECHNOLOGIES
TMF Review, Monitoring & SDV, CAPA Management
Executive – Quality Assurance
Anacipher CRO
September 2015 – July 2017
- Reviewed BE/BA protocols and reports for regulatory compliance.
- Performed in-process audits (clinical sampling, documentation, vendor audits) and tracked SOP deviations and CAPA.
- Supported documentation control, audit preparation, and study compliance.
TECHNOLOGIES
SOP Deviation Tracking, Protocol/Report Review, QA Documentation
