Bharat Sonkusale

About Bharat Sonkusale

Overall 11 years of experience in clinical research industry.6.5 years of experience in clinical data management activities in study conduct and closeout activity.knowledege of clinical trials documents such as SOP, Protocol and study eCRF guidelines.Working knowledge of clinical database tools such as RAVE, iMedidata and Inform.Working experience on clinical studies- Oncology and other Thereupatic areas ( phase I II and IV).5 years of experience in Clinical Research Records and information Management (eTMF).Knowleged of ICH-GCP guidelines, Essential documents in clinical trials.Working knowelege of tools used in document managements like ELVIS, EEL-C and FirstDoc server used in healthcare for archiving data generated via clinical trials at various sites.Knowelege of PSMT, ENF submission process and Pre-DIA to DIA migration. Specialities: Medidata, RAVE, InForm, ICH-GCP guidelines, Indexing, Pre-QC and Review QC. Mentoring new joiners, Document tracking and validation, uploading document via EEL-C.working on tool RAVE EDC

Experience

1. Senior Clinical Data Coordinator

   ICON plc

   Jul 2023 — Present · Bengaluru, IN

   Recognize, exemplify and adhere to ICON\'s values which center around our commitment to people, clients and performance.• As a member of staff, the employee is expected to recognize the importance of and create culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.• Read, ensure understanding and adhere to all assigned ICON SOPs and working procedures.• Ensure all work performed is of high quality, compliant with Good Clinical Practices ICh Guidelines and all applicable laws and regulations. • Complete all assigned trainings (including the study lead development program) and courses in the ICON Training management system (ilearn); ensuring that Mandatory courses are all completed before the designated date and that the required system specific training has been completed for current studies.• Record all billable and non-billable time in the appropriate timsheet management system.• Review CRF/eCRF data for completeness, accuracy, and consistency via computerize edits and manuall data checks.• Perform external data reconciliation.• Perform Serious Adverse Events reconciliation.• Generate and close/resolve (as appropriate) data queries.• Freeze and/ or Lock eCRFs (as appropriate) within the Electronic Data Capture System.• Create and maintain study files and other appropriate study documentation.• Perform User Acceptance Testing (UAT) and collaboratively work with CDMS personnel to see issues found through re-testing and resolution.• Assist Data Management study lead in development of eCRF, Data Validation Specifications,and study specific procedures.• Train and guide less experienced CDCs in data management requirements and activities.• As required, communicate effectively with the Project team, Study Lead, Project Lead and Project Managers.

Education

• APOLLO HOSPITAL EDUCATIONAL & RESEARCH FOUNDATION, HYDERABAD

  ADVANCE POST GRADUATE DIPLOMA COURSE, Clinical Research

  2012 — 2013

• PRIYADARSHINI INSTITUTE OF ENGG & TECHNOLOGY

  B.TECH, BIOTECHNOLOGY

  2007 — 2011

Skills

• Microsoft Office
• Powerpoint
• Microsoft Excel
• Clinical Trials
• Microsoft Word
• Clinical Research
• Life Sciences
• Biotechnology