Shilpa Fernandez M
Trial Master File Specialist | 3+ Years in Clinical Research | Expertise in Regulatory Compliance, Site Management, and Quality Assurance | Proficient in ICH-GCP, ALCOA+, and Clinical Data Systems
- Role
- Tmf Specialist i at ICON plc
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Shilpa Fernandez M
Results-oriented operations and compliance professional with 4.5+ years of global…
Experience
Tmf Specialist i
Feb 2023 — Present · Chennai, IN
As a Trial Master File Specialist, ensured adherence to ALCOA+, GCP, GDP, and ICH E6 (R2) guidelines while managing and processing critical study documents. Spearheaded quality checks to ensure accuracy, completeness, and compliance, contributing to the integrity of clinical documentation. Prepared detailed project progress reports, identified areas of concern, and provided actionable insights to drive timely decision-making. Played a key role in mentoring and training junior team members, creating training materials, and fostering a cohesive, compliant team environment. Collaborated with cross-functional teams to resolve document-related issues, optimize workflows, and meet project timelines and quality metrics. Successfully led process improvement initiatives to enhance operational efficiency and align with business objectives. Additionally, analyzed training feedback and performance data to measure the impact of initiatives, reported findings to senior management, and contributed to seamless project management through meticulous daily work progress reporting.
Education
Mohandas College of Engineering &Technology, Nedumangad, Thiruvananthapuram.
Bachelor of Technology - BTech
2015 — 2019
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