Nimisha W.
Mid-Level Clinical Trial Document Specialist
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Nimisha W. is a detail-oriented clinical research professional with extensive experience in managing Trial Master File (TMF) documentation in compliance with regulatory standards. She is skilled in handling eTMF systems, including Veeva Vault, Wingspan, and ELVIS, and performing quality reviews to maintain inspection readiness in accordance with ICH-GCP guidelines. Nimisha has been a TMF Specialist at IQVIA in Bangalore since June 2019, where she conducts comprehensive quality reviews of TMF files and mentors new team members. Previously, she worked as a Document Specialist through Technosoft Global Solutions LLP, focusing on document indexing and quality management. Her role as a Clinical Research Coordinator at M S Clinical Research Pvt Ltd and Lotus Labs Pvt Ltd involved assisting with subject recruitment and coordinating study activities per protocol. Nimisha holds an MSc in Biotechnology from the Vydehi Institute of Biotech Sciences and is certified in ICH GCP E6(R3). She has been recognized with several awards for her exceptional work quality.
Experience
Document Specialist
IQVIA/Technosoft-Bangalore · 2019 — 2020Managed the uploading, indexing, and quality checks of documents in Veeva Vault. Conducted pre-quality checks, created batches in EEL-C, and performed indexing and quality review in ELVIS according to SOP and guidance documents. Executed quality checks in Wingspan and I-eTMF within established timelines.TMF Specialist
IQVIA-Bangalore · 2019 — PresentConducted thorough quality reviews of TMF files in accordance with eSOPs, Guidance documents, and Project instructions. Reviewed documents following ALCOAC principles and ensured accurate filing per the DIA TMF Reference Model, identifying metadata inaccuracies and creating Action Items. Focused on checking for and identifying missing documents, provided mentoring sessions for new joiners, and supported audits and inspections by maintaining TMF readiness.Clinical Research Coordinator
M S Clinical Research Pvt Ltd-Bangalore · 2018 — 2019Assisted the Principal Investigator in recruiting subjects and coordinated subject visits as per study protocol. Managed IP storage, handling, and maintenance, and reported adverse events (AE) and serious adverse events (SAE). Supported CRAs during Site Selection Visits, Site Initiation Visits, and site closeouts, ensuring timely responses to queries. Attended Investigator Meetings as required and tracked the inventory of IP and laboratory supplies at the site. Maintained the eCRF and EDC, along with ISF and subject file maintenance, coordinating study-related activities among personnel for smooth execution.Clinical Research Coordinator
Lotus labs Pvt Ltd-Bangalore · 2013 — 2013Assisted the Principal Investigator in subject recruitment while coordinating subject visits according to the study protocol. Handled the storage and maintenance of investigational products (IP) and reported adverse events (AE) and serious adverse events (SAE). Provided support to CRAs during Site Selection Visits, Site Initiation Visits, and site closeouts, ensuring timely query responses. Attended Investigator Meetings as requested and tracked the inventory of IP and laboratory supplies. Maintained the eCRF and EDC alongside ISF and subject file maintenance, coordinating all study-related activities amongst various personnel to facilitate smooth study execution.
Skills & Expertise
Education
- MSc in BiotechnologyVydehi Institute of Biotech Sciences- Bangalore University · 2010 — 2012
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