Kajal Sharma Netram
TMF Specialist | Clinical Research | eTMF & Compliance | Document Management | Regulatory Submissions | Process Improvement | Audit Readiness | Ensuring Excellence in Clinical Trials
- Role
- Tmf Specialist at Fortrea
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Kajal Sharma Netram
As an experienced Clinical Research Professional with 8 years of expertise in the Pharmaceutical industry, I possess a strong knowledge of drug development, clinical phases, and medical writing, including Clinical Study Report (CSR) and Informed Consent Forms (ICF). Additionally, I am skilled in Electronic Data Capture (EDC), eTMF, and Clinical Trail Management System (CTMS), along with proficiency in MS-Office.My understanding of ICH regulations and Good Clinical Practice (GCP) is extensive, and I have a proven track record of successfully leading projects and collaborating with cross-functional teams. I take initiative to work independently, confidently and am a quick learner, always ready to acquire new skills.I am excited about the opportunity to leverage my expertise and skills in a challenging position that utilizes my strengths, enabling me to contribute to the success of the organization.
Experience
Tmf Specialist
Mar 2023 — Present · Bengaluru, IN
E-TMF Management: Setup, maintain, and organize the electronic trial master file (e-TMF) for clinical studies, including trial, country, and site artifacts.Regulatory Compliance: Maintain current knowledge of applicable regulatory requirements and ensure documentation meets standards throughout the trial lifecycle.Index Mapping and Maintenance: Map sponsors\' TMF index to the Covance TMF index and add or modify TMF artifacts according to SOPs.Quality Assurance: Conduct visual quality checks on e-documents to confirm image clarity and readability. Perform Audit Ready Checks on individual documents to ensure accuracy and compliance.Project Coordination: Monitor project progress, communicate effectively with stakeholders, and ensure strict adherence to deadlines and budgets to produce high-quality deliverables.
Education
Jain university
Bachelor of Applied Science (B.A.Sc.), Life Science
2010 — 2013
University of Nottingham
Master's degree
University of Nottingham
Master's degree, Applied Biomolecular Technology
2013 — 2014
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.