Santosh Viswanadh
Senior Clinical Data Coordinator at Icon plc a Health care intelligence company.
- Role
- Senior Clinical Data Coordinator at ICON plc
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Santosh Viswanadh
Responsible for all the Clinical Data Management activities from Start to End and the therapeutic areas involved is “Oncology”, “Respiratory”, “Cardiovascular”, “Rheumatoid Arthritis”. Handling a major COVID 19 Project for one of the world’s leading Pharmaceuticals. Creates Back End checks and SAS listings and performs their review. Responsible for review, maintenance and update of External Vendor data received from central laboratories and local laboratories. Working to ensure departmental SOPs, guidelines, and global standards are followed to maintain data integrity and ensure consistence across all projects. Hands on experience in Discrepancy management and UAT. Perform the daily review of CRF’s for Completeness, Accuracy and Consistency. Hands on experience in study startup phase, conduct phase, and close out phase For Rave and OC as well. Hands on experience on SAE reconciliations. Knowledge on RECIST Criteria. Maintain DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements. Perform User Acceptance Testing for Rave and OC studies. Review and Resolve data discrepancies identified by the system or through manual checks in Rave and OC as well. Generate data query forms to be resolved at investigational sites and enter resolutions into database OC. Perform CRF entry and Quality control of the data. Review clinical data as per SOP, Protocol, and study specific guidelines. Review Case Report Forms track missing CRFs for the study. Well-versed with industry standards like 21 CFR Part 11, ICH GCP, CDISC. Maintaining Clinical Study Documents and archiving as appropriate. Understand and comply with all applicable standard operating procedures and working instructions.
Experience
Senior Clinical Data Coordinator
Apr 2023 — Present · Bangalore Urban, IN
Education
Aditya junior college
11th and 12th
2010 — 2012
Singhania University
Master's degree, Bioinformatics
2020 — 2022
Cliniminds
Advanced post graduation diploma in clinical research and clinical data management, Clinical research
2016 — 2016
Adikavi Nannaya University, Rajahmundry, East Godawari
Bachelor of Science - BS, Biotechnology, Microbiology, Biochemistry
2012 — 2015
SAS institute india pvt ltd
Clinical SAS programming and Biostatistics, Human Data Sciences
2021 — 2021
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