Samiksha Badjate
eTMF (Trial Master File) Quality Specialist || eTMF Document Reviewer | Clinical Operations at Tata Consultancy Services, Pune
- Role
- Etmf Quality Specialist Clinical Operations at Tata Consultancy Services
- Location
- Nashik, IN
- LinkedIn followers
- 500 followers
About Samiksha Badjate
Professionally qualified with an experience of 3+ years in eTMF/Clinical Operations. • Currently working as an eTMF Quality Specialist in Clinical Operations at Tata Consultancy Services (TCS), Pune. • Mastery in eTMF Document Reviewer, eTMF QC\'er, Uploading of eTMF Documents. Also, contributed in the project like Reclassification of eTMF documents, Deletion Request Logs, Quality Issue Log (QIL). • Periodic reviewing and approving Essential documents obtained from the clinical trials. • Good knowledge of applicable clinical research regulatory requirements; i.e, International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines. • Experience in ensuring the clinical trial documentation it is consistent with the TMF Master Index, study specific expected document list, submission and inspection readiness criteria and comply with SOP’s and other requirements. • Knowledge and expertise with DIA TMF Reference Model. • Knowledge of Clinical development phases and 21CFR. • Good command over Veeva Vault TMF system. • Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook). • Training and Mentoring new associates taking active measures to solve problems and commit to a high level of service. • Multitask in a fast-paced environment. • Recognized consistently for excellent performance and contribution to the team for handling workflow efficiently.
Experience
Etmf Quality Specialist Clinical Operations
Dec 2019 — Present · Pune, IN
Education
Mumbai Educational Trust, MET League of Colleges
Bachelor of Pharmacy - B Pharm
2015 — 2019
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