SHRIDEVI AMMENADKA
Summary
Results-driven Senior Clinical Trial Associate with over 3 years of hands-on experience in clinical trial operations, specializing in eTMF management, regulatory document tracking, and ensuring audit readiness across diverse therapeutic areas. Demonstrated expertise in leading cross-functional teams to streamline workflows and enhance efficiency throughout the study lifecycle, from start-up to closure. Recognized as a subject matter expert (SME) for Trial Interactive (TI) and Veeva systems, overseeing system upgrades and effectively resolving queries. Committed to mentoring junior CTAs and fostering high-quality, compliant trial documentation while contributing to patient-centered drug development in the RNA therapeutics field.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Senior Clinical Trial Associate
Caidya
10.2024 - Current
- Lead end-to-end eTMF management in Veeva and Trial Interactive, including set-up, maintenance, configuration updates, document QC, and study closure, ensuring inspection-readiness in compliance with SOPs and ICH-GCP.
- Oversee multiple global studies, delivering monthly eTMF KPI metrics , resolving queries, and monitoring trends to proactively improve TMF quality and completeness.
- Act as eTMF subject matter expert , providing onboarding, access management, troubleshooting, and user support for study teams and vendors.
- Successfully managed sponsor audits for multiple studies, resulting in minimal findings and demonstrating a strong commitment to maintaining high standards of compliance.
- Collaborate with cross-functional stakeholders to manage essential documents, prepare study templates, and maintain study-specific tracking systems.
- Provide mentorship to junior CTAs , and other cross functional teams on TMF training, reviewing QC processes and supporting training in TMF best practices.
- Contribute to operational excellence through strong organizational skills, proactive issue resolution, and streamlined documentation workflows.
Clinical Trial Associate
Caidya
01.2023 - 09.2024
- Collaborated with global internal and external study team members, supports all phases of the study under departmental and/or study team supervision.
- Effectively managed administrative functions such as minute taking, data entry, tracking, scanning/copying, binder creation, and supply distribution.
Administrative Assistant
Best Brains Learning Center
09.2018 - 02.2020
- Successfully managed day-to-day administrative duties include writing, editing, and proofreading internal and external emails, and documents.
- Monitored and reviewed students' academic progress and updated data in the database.
- Assisted in the daily maintenance of the classroom environment through assistance with setup, cleanup, and organization of materials.
- Effectively communicated to build strategic relationships with clients, parents, and staff.
Research Associate
St. John's National Academy of Research Center
08.2009 - 03.2011
- Assisted Principal Investigator in daily operations of proteomics lab and provided support for projects per company SOPs and ICH-GCP guidelines.
- Conducted clinical investigation in accordance with GLPs. Successfully entered and reviewed data by effectively communicating with internal and external clinical investigators.
Chemistry Lecturer
St. Sebastian Pre-University College
08.2007 - 08.2008
- Independently created and delivered university-level lesson plans and assisted in lab planning with SOPs, GLPs.
- Supervised diverse students in performing requisite chemistry experiments safely in accordance with the University curriculum and safety regulations.
- Evaluated student performance and administer examinations.
Education
M.Sc. - Biochemistry
Mangalore University
B.Sc. - Science
University College
Clinical Research Specialist
Wake Technical Community College
Raleigh, NCMonitoring Clinical Trials
Wake Technical Community College
Raleigh, NCSkills
- eTMF Management (Veeva, Trial Interactive)
- Audit/Inspection Readiness & Minimal Findings in Sponsor Audits
- Regulatory Document Management
- Clinical Trial Operations
- ICH-GCP Compliance
- Quality Control & Metrics Reporting
- Cross-functional Collaboration
- Study Start-Up & Site Activation
- Mentorship & Training
Websites
Certification
Independently Accredited TMF Professional – IAOCR Certified
Timeline
Senior Clinical Trial Associate
Caidya
10.2024 - Current
Clinical Trial Associate
Caidya
01.2023 - 09.2024
Administrative Assistant
Best Brains Learning Center
09.2018 - 02.2020
Research Associate
St. John's National Academy of Research Center
08.2009 - 03.2011
Chemistry Lecturer
St. Sebastian Pre-University College
08.2007 - 08.2008
B.Sc. - Science
University College
Clinical Research Specialist
Wake Technical Community College
Monitoring Clinical Trials
Wake Technical Community College
M.Sc. - Biochemistry
Mangalore University
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