YAMINI S ACHARYA
Specialist- Clinical Trial Coordinator
Kushalnagar
Summary
Reliable business professional with 5+ experience in clinical trial support, process improvement and central monitoring. Proven track record of successfully streamlining processes and increasing efficiency. Adept at analyzing data to identify trends and developing strategies to reach project goals.
Overview
6
6
years of professional experience
2
2
Certifications
4
4
Languages
Work History
Specialist- CTC
Merck Specialties Private Limited
Bengaluru
4 2024 - Current
- Support Quality Issues in Veeva eQMS
- Maintain SUSAR distribution lists and quarterly compliance reviews
- Track provision of safety listings from external Sponsor-Investigators
- Created dashboards/system analytics to analyse study metrics, site performance, quality, recruitment, site engagements, etc
- Support Clinical delivery leads in reviewing Site visit reports
- Established data driver oversight activities and drafted action items to CROs
- Support COT Meetings Organization
- Act as mentor/coach to junior CTCs
- GDO Resource management/staff list
- Perform Clinical Management Landscape (CML) CTMS data entry & QC, update Trial Team and Vendor Lists, manage Clinical Site and Investigator data in OnPoint and SharePoint, coordinate reporting if required
- Perform STARTOne data entry (portal to register and process regional and local portfolio, maintenance & QC.
Senior Analyst- CTC
Merck Specialties Private Limited
07.2023 - 04.2024
- Support Audits & Inspections in Veeva eQMS, follow up on Action items until closure
- Support Deviation and Risk management in Veeva eQMS
- Maintain SUSAR distribution lists and quarterly compliance reviews
- Track provision of safety listings from external Sponsor-Investigators
- Perform Safety Desk tasks for OSM (Optimized Sourcing Model) studies.
Analyst- Clinical Trial Coordinator (CTC)
Merck Specialties Private Limited
06.2021 - 07.2023
- Provide CAPA Tracking
- Maintain SUSAR distribution lists and quarterly compliance reviews
- Track provision of safety listings from external Sponsor-Investigators, perform reconciliation against Safety Database
- Track Site interaction visits, review DM reports and support data cleaning
- Support Inspection Preparation & Inspection Readiness related activities
- Support Clinical Operation Teams (COT) Meetings Organization
- Support Study Teams with handling of site communication and filing
- Provide Regional Dashboards, prepare systems analytics
- Ensure data in critical source systems are up to date, provide necessary dashboards, reports through use of appropriate business software
- Perform Safety Check Desk tasks 24/7 for ICSRs, create queries in EDC, follow up with site for open actions
- Support study teams with admin support (reports, dashboards, platforms, and access management)
- Perform Analytics on Performance and Quality.
Central Monitor (CM)
IQVIA
02.2020 - 06.2021
- Complete role specific trainings in a FSP model
- Perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned studies
- Reviewing i-site packs to verify IP has been dispensed and administered to subjects according to protocol and also site has sufficient lab kits for subject visit
- Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan
- Delivery of Remote Monitoring Summary and Fortnight Reports
- Remote data review (eCRF)
- Manage operational insight of assigned project(s) and complete study/site metrics trending (trend analysis of clinical aspects of trial, share trends and agree on action plan, review, triage, and action clinical study alerts, monitor clinical monitoring plan (CMP) compliance etc.)
- Review all reported SAEs to ensure reporting timelines, patient safety and eCRF completion
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for project specific information
- Resolved Missing Pages and Queries of sites
- Helped to identify Protocol Deviations and proposing resolution
- Helping remote resolution of Action Items for CRAs
- Review all inclusion and exclusion criteria to ensure each patient meets minimum level of acceptance into clinical trial as per protocol
- Review all reported Concomitant Medications/prohibited medication to ensure no medication is disallowed per protocol, supports existing reported medical condition, or prescribed for reported AE
- Complete day to day tasks ensuring quality productivity
- Support in creation of new templates and performing UAT
- Task management in tool
- Working closely with client to meet study milestones.
Centralized Monitoring Coordinator (CMC)
IQVIA
05.2019 - 02.2020
- Clinical Trackers & Reports maintenance
- ETMF Document track and upload
- Training compliance of clinical team and reports
- Following-up for open AIs with CRA's between monitoring visits
- Created trackers to meet study deliverables on time.
Centralized Monitoring Assistant (CMA)
IQVIA
10.2018 - 05.2019
- Complete appropriate role-specific training to perform job duties
- Running system reports, preparing, and distributing status reports, creating, and maintaining study documents
- Assist study leads for maintaining trackers and access management.
Education
Bachelor of Engineering - Biotechnology
Saptagiri College of Engineering
Bengaluru, India 04.2001 -
HSC & SSC
Jawahar Navodaya Vidyalaya
Madikeri, India05.2014
Skills
eTMF, Wingspan, Veeva Vault, ELVIS
EDC (iMedidata Rave, Medrio, CubeCDMS, Inform)
IXRS
CTMS Infosario (Clinical Analytics)
Spotfire
Vendor And Sponsor Platforms
MS Office
Analytical Skills
Process Improvement
Trend Data Analysis
Certification
Advance Program in Clinical Research and Data management
Disclaimer
I hereby declare that above information is true to the best of my knowledge
Timeline
Senior Analyst- CTC
Merck Specialties Private Limited
07.2023 - 04.2024
Analyst- Clinical Trial Coordinator (CTC)
Merck Specialties Private Limited
06.2021 - 07.2023
Central Monitor (CM)
IQVIA
02.2020 - 06.2021
Centralized Monitoring Coordinator (CMC)
IQVIA
05.2019 - 02.2020
Centralized Monitoring Assistant (CMA)
IQVIA
10.2018 - 05.2019
Bachelor of Engineering - Biotechnology
Saptagiri College of Engineering
04.2001 -
Specialist- CTC
Merck Specialties Private Limited
4 2024 - Current
HSC & SSC
Jawahar Navodaya Vidyalaya