Nitesh Soni
CDISC consultant
- Role
- Sr Principle Clinical Data Standard Consultant at ICON plc
- Location
- Thane, IN
- LinkedIn followers
- 500 followers
About Nitesh Soni
I am a clinical research professional with more than 16 years of experience in life science industry & out of which 15 years of experience in clinical data management. Core competencies include SDTM data handling & programming, SME support to the project, project management of clinical operations, vendor management, resource planning, problem solving, strategic planning. Also, proven ability to manage clinical research projects of all phases, develop credible guidelines, SOPs and efficient processes, drive and implement quality initiatives, manage large teams, and implement cost saving measures through the use of proven conceptual and analytical problem solving abilities. Academically, I have a done masters (MBA) in Healthcare Services & Post Graduate Diploma in Clinical Data Management. Short summary of my work experience:# Practical exposure & depth knowledge of SDTM annotations, Study metadata creation (Define.xml), Trial Design Domains development, SDTM programming, Validation of domains using Pinnacle checks, Clinical Study Data Reviewer\'s Guide, Critical Business rules development and EPOCH implementation rules development # Worked as single point of contact for Sponsor (clinical team, study statistician ) & internal stakeholders & ensure project deliverable\'s are met on time with quality # End to End practical exposure of SDTM data handling start with setup of all required study documents & end with submission of SDTM data transfer to sponsor # Practical knowledge of handling blinded/unblinded SDTM data processing and handling Pharmacokinetic data in a study # Practical knowledge of fulfilling e-Submission requirement OR completing necessary documentation like completing document properties and hyperlinking/ bookmarking of SDTM annotations # Good understanding of SDTM IG V3.1.3, SDTM fundamentals & CDASH standards # SDTM Trainer & senior mentor in a project # People Management, productivity and utilisation calculation for resource planning
Experience
Sr Principle Clinical Data Standard Consultant
Jan 2023 — Present · Mumbai, IN
Education
K.C College
Post Graduate Diploma In Medical Laboratory Test Test, Chemistry
2006 — 2007
S.P.H High School / N.B Mehta Science College
Bechelor, Chemistry
1995 — 2005
Institute of Clinical Research, India (ICRI)
Post Gradiate Diploma In Clinical Data Management (PGCDM), Clinical Data Management
2007 — 2008
Sikkim Manipal University of Health, Medical and Technological Sciences
MBA, Health Care Services
2008 — 2010
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