Monisha

Clinical research professional with 3.5years of experience as a TMF Specialist and CRC Skilled in Periodic file reviews, quality checks, metadata analysis, Hands on experience across Veeva Vault, PTMF and IeTMF platforms. providing training,guidance,and query resolution to team members.

TMF Document Specialist - IQVIA RDS (India) Pvt. Ltd. - Bengaluru, India

(2024-05)

• Conduct Comprehensive Quality Trial Master File Review in adherence with eSOPs, Guidance Documents.
• Conduct periodic file review, cross-checks and co-dependency assessments to identify missing documents in Veeva Vault and IeTMF.
• Perform ALCOA-based quality checks and metadata validation to ensure document accuracy, completeness, and compliance.
• Execute detailed file reviews and study item listings, resolving metadata discrepancies within defined timelines.
• Ensure completeness, accuracy, and high-quality standards of TMF documents throughout the clinical trial lifecycle.
• Proactively follow up with stakeholders to drive timely closure of TMF action items, improving workflow efficiency and compliance.
• Review documents within agreed timelines, consistently achieving 100% completion of cross-checks and co-dependency checks.
• Actively communicate findings, trends, file review-related questions and escalations to QPM.
• Maintain an inspection-ready TMF for all assigned studies at all times.

Clinical research coordinator - ChanRe Rheumatology and immunology Center and research - Bangalore Karnataka

(2023-02 - 2024-04)

• Coordinated clinical trial activities including patient recruitment, screening, and enrolment.
• Maintained source documents, CRFs, and ISF.
• Understanding and ensuring study activities in compliance to protocol.
• Informed consent documentation
• Screening subjects for eligibility using protocol specific inclusion and exclusion criteria and documenting each potential participant's eligibility or exclusion
• Data collection and timely completion of case report forms.
• Drug or device accountability logs
• Electronic Data Capture

Clinical Research and Data Management - Bangalore clinical research institute (2022)

B.sc - Biotechnology - Vijayam science and arts degree college (2021)