Sayali Raje
Information Processing Specialist @Tata Consultancy Services
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WORK HISTORY
Information Processing Specialist @Tata Consultancy Services
Mumbai, IN
Responsible for providing operational support to multiple study management teams through all phases of the study (startup, conduct, closeout) in accordance with applicable quality standards including ICH/GCP and local regulatory guidelines. Create study specific documents and track and provide key study metrics In Clinical Operations Lead and manage study delivery of global clinical trials by coordinating with clinical study. sites,CROs/vendors, global study team and other functional areas, during start-up and maintenance through out close-out of clinical studies. Track and maintain study information in CTMS & eTMF and related study report progress. Proactively incorporate learning and recommendations during study debriefs. Ensure GCP and other regulations including ethics committee are adhered to by the study teams. To be well versed with work instructions/SOPs/Protocol from Audit Perspective and follow the client/internal protocol that is applicable. Communicate current or anticipated issues along with risk mitigation plans and lessons learnt. eTMF Activities: Perform quality checks of all start-up activities with focus on essential documentation and eTMF, ensuring compliance with regulatory standards. Coordinating directly with clients as required. Performing periodic TMF reviews, report findings and confirm closures. Manage document uploads and resolve related queries. Vendor Management: Coordination and communication between vendor, study team, and CRO for defined tasks and tracking information. Managing vendor system access, trackers and data. Veeva Activities: Understanding the Concept of lifecycles,which are closely linked with milestones and documents. Learn about milestones templates for study,Country,site level and managing through out study lifecycle. Creating,uploading and classifying documents. track and manage issues and follow up with study and country team for effective task management.
EDUCATION
Shivaji University, Kolhapur
Bioinformatics
MSBHSE
High School Diploma
Shivaji University, Kolhapur
Bachelor of Science
Shivaji University, Kolhapur
Master's degree, Biochemistry
Clinomic Center for Clinical Research Pvt. Ltd.
Diploma of Education, Clinical Research
Shivaji University, Kolhapur
Postgraduate Degree, Bioinformatics
Shivaji University, Kolhapur
Master of Science, Biochemistry
ABOUT SAYALI RAJE
Experience in clinical Research more than 3 years strong knowledge of hospital health care policy more concerned about patient safety and health. Skilled in Biotechnology,Biochemistry and Bioinformatics.Strong knowledge of ICH-GCP,Good clinical Practice and.Currently looking for role a which allows me to learn my area of knowledge and Clinical research Skills and flourish in this field.
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