Swapnil Thorat

About Swapnil Thorat

I have over 13.5 years of experience in Clinical Data Management, specializing in EDC (Electronic Data Capture) based clinical trials. Throughout my career, I have gained a deep understanding of the processes and workflows involved in Clinical Data Management operations.I am proficient in working with various Clinical Data Management systems such as Medidata Rave, Rave X, Inform, Datalabs, and OC-RDC. I have used these systems effectively to perform study setup, conduct and closeout activities in Global clinical trials.My expertise in Clinical Data Management includes a wide range of responsibilities. I have experience in database designing, user acceptance testing, data validation, discrepancy management, medical coding, Serious Adverse Event (SAE) reconciliation, drafting data transfer specifications, central and local lab data reconciliation, vendor data reconciliation, database locking, and the creation, review, and finalization of study documents.As a Subject Matter Expert (SME), I have been involved in Protocol Deviation process improvement initiatives. In terms of therapeutic areas, my expertise lies in Hematology, Oncology, Transplantation, Vaccine, Respiratory, Optha, Early Phase Oncology studies, RLI/RLT and Cell and Gene Therapies. I have worked on projects within these areas and have a comprehensive understanding of their specific requirements.In addition to my Clinical Data Management expertise, I have also led the Business Process Risk Assessment (BSPRA) for a significant project involving the migration of data from one EDC (Electronic Data Capture) platform to another. As part of this first-in-industry in-house Data Migration Project, I was responsible for conducting a thorough assessment of the business processes involved in the migration. The goal was to identify any potential risks and develop strategies to mitigate them effectively. My experience in leading the Business Process Risk Assessment for a complex data migration project demonstrates my ability to apply a systematic approach to identify and manage risks effectively.Overall, my extensive experience in Clinical Data Management, proficiency with various systems, and expertise in therapeutic areas make me an asset in the field of Clinical Research.

Experience

1. Senior Principal Clinical Data Scientist

   Novartis

   Apr 2023 — Present · Hyderabad, IN

   As a Senior Principal Clinical Data Scientist, I currently oversee all clinical data management tasks across multiple oncology projects, from database setup to database lock.• Provides Data Management leadership for one or more assigned programs/projects or indications.• Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i:e ensuring consistency across data quality plans• Develops an understanding of CDISC or other recognized industry standards and how these impact the programming team. Ensures consistency of program level standards. • Communicates and negotiates effectively with all other Program level team members. Primary point of contact for DM at the GPT level.• Maintains awareness of the status of start up, conduct and finalization activities for all trials within assigned program(s) Tracks and requests necessary resources. Ensures the key study risks & issues are shared in the Project Review Meeting.• Demonstrates an effective application of knowledge across all DM scenarios. Is able to provide solutions to effectively meet timelines• Manages effective escalation of issues in order to keep stakeholders appraised of DM activities and proposed resolutions• Supervises and drives the overall DM timelines across assigned programs. Reviews the Data Management Metrics on the assigned Program.• Coaches and mentors associates as required, ensures that DM associates on the program are aware of the risks, priorities, goals and impact of the work contribution.• Develops risk management strategies to prevent data quality issues from derailing projects• Represents Data Management at cross functional forums, meetings and provides timely feedback to partners.• Understands Health Authority requirements and is able to prepare for and participate in Health Authority inspections and audits as required.

Education

• University of Mysore

  PGD , PGD in Clinical Research and Clinical Data Management

  2011 — 2012

• Sikkim Manipal University (SMU)

  Master of Business Administration (MBA), Project Management

  2013 — 2015

• Southern New Hampshire University

  Master of Science - MS, Psychology

• Jawahar Navodaya Vidyalaya - JNV

  12th, CBSE, PCMB

  2007 — 2008

• Punyashlok Ahilyadevi Holkar Solapur University, Solapur

  B.Sc, Biotechnology

  2008 — 2011

• Indian Institute of Management Rohtak

  Executive Program in Project Management, Project Management

  2023 — 2024

Skills

• Oc Rdc
• CRO
• CRO Management
• Medidata Rave
• Clinical Data Management
• Oracle Clinical
• Ctms
• Life Sciences
• Pharmaceutical Industry
• Project Management
• Clinical Research
• Ich-Gcp
• Molecular Biology
• Operational Risk Management
• Inform
• Lifesciences
• Good Clinical Practice (Gcp)
• Clinical Risk Management
• Datalabs
• Clinical Development
• Microbiology
• Clinical Trial Management System (Ctms)
• Clinical Trials