Swapnil Thorat Email and Phone Number
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I have over 12 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.
Novartis
View- Website:
- novartis.com
- Employees:
- 100036
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Senior Principal Clinical Data ScientistNovartis Apr 2023 - PresentHyderabad, Telangana, IndiaAs 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.
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Principal Clinical Data ManagerNovartis Apr 2020 - Mar 2023Lead functional activities for a medium to large sized project in phase I to IV clinical studies. Co-ordinate activities of Data Managers either internally or externally. Make data management decisions and propose strategies at study or project level.Ensure application of consistent data management processes, influence increased standardization and documentation across assigned project/programsComply with company, department and industry standards and processes. Provide and implement data management solutions; ensure knowledge sharing.Leads process and training deliverables within multiple platforms, franchises or therapeutic areas Develops strategies to ensure effective training and knowledge retention.Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical data management aspects.Represents DO in all audits and inspections, centralizing and aligning the team in audit preparation, readiness and response.Manages and measures quality -Coordinates exception requests, deviations and corrective/preventative action plans Ensure timely and quality development/ validation of CRFs and edit specifications for assigned studies/programs Responsible for quality control and audit readiness of all assigned data management deliverables as well as accuracy and reliability of the clinical database.Coaches and mentors associates as required -Act as subject matter expert (SME) or, as assigned, lead process improvement/non -clinical project initiatives. Develops risk management strategies to prevent data quality/coding issues from derailing projectsManages effective escalation of issues in order to keep stakeholders appraised of DM activities and proposed resolutionsRepresent Data Management at audits and in Health Authority (HA) meetings for assigned project(s)
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Senior Clinical Data ManagerNovartis Jun 2017 - Mar 2020Leading and Performing all Data Management activities in Start up-Conduct-Lock-Post lock phase for oncology trials. Area of Expertise: Hematology/Oncology/Transplantation/ Vaccine/Respiratory/Early Phase oncology studies, Cell and Gene Therapies. Tools: Medidata Rave, Inform, Datalabs, OC-RDC, iMedidata Rave, Rave X, • Serves as the primary Data Management interface for internal project team members and external data vendors and ensure effective communication exchange.• Ensures the timely initiation, conduct, and completion of Data Management activities on clinical trials.• Tracks and Manage the Data Management timelines for assigned projects and ensures that all applicable Data Management team members are aware and on target for deliverable. • Review protocols for appropriate data capture including electronic Case Report Form (e-CRF) design.• Perform a thoroughly detailed review of e-CRF data requirements and interact with programmers, standards, safety team, study managers, statisticians, clinical and medical team in designing e-CRFs and CRF completion guidelines.• Lead the development of edit check specifications and data listings, custom reports, patient profiles. • Coordinate the design and testing of Electronic Data Capture (EDC) systems, tSDV testing according to company standards. Able to resolve EDC system issues with cross function collaboration. • Develop and lead the development of the Data Management Plan, Data Handling plan, Data Quality Plan for a clinical study.• Review and provide feedback to the clinical team on other study documents. • Conducts project-specific training throughout the course of the project, as needed.• Attends and presents at the different project meetings as required.• Oversees the completion of a comprehensive data review of clinical data.• Authors the Data Transfer Specifications with third party external data vendors• Ensures DM documentation is audit-ready and filed appropriately at all times.
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Clinical Data Analyst IiParexel Dec 2015 - Jun 2017Bengaluru Area, IndiaArea of Expertise: Hematology/Oncology/Transplantation/ Vaccine Tools: Medidata Rave, Inform, Datalabs, OC-RDC, MS-Word/ Excel/ PowerPoint/outlook/Access• Assume the ability to meet the requirements of a CDA I and CDA II with a high degree of proficiency and autonomy.• Take responsibility for specific tasks on projects, or acts as the main CDA contact on individual projects.• Train team members on selected tasks.• Prepare Data Cleaning Specification.• Develop or provide input to project specific guidelines.• Utilize current study documentation including protocol, Case Report Forms (CRFs), cleaning guidelines.• Development of database build specifications • Development of data validation specifications • Perform the Test data creation & UAT • Perform Data validation and cleaning • Conduct medical coding if assigned • Generate and close queries or apply self-evident corrections to the data according to the relevant guidelines• Identify and report protocol violations.• Manual and Patient Profile review, issue queries• Conduct reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action.• If required liaise with 3rd party vendors to clean electronic data.• Perform early and final database QC activities• Perform Database lock activities• Maintaining Clinical Study Documents and archiving as appropriate during the course of trial• Responsible for completeness, timely delivery and quality of clinical trial data as per the customer’s requirement. • Update all relevant tracking system on an ongoing basis and prepare status reports. -
Senior Clinical Data CoordinatorIqvia Apr 2015 - Dec 2015BangaloreTherapeutic Area of Expertise: Oncology/ Hematology/Transplantation Serve as Data Operations Coordinator (DOC) for one or two global studies with fewer than 10 operations staff (excludes DE), or serve in a leadership role to a specific DM Task. Manage delivery of projects through full data management study life-cycle (with minimal guidance). With guidance from DTL or Manager, manage project timelines and quality; determine resource needs; identify out-of-scope work. Serve as Data Operations Coordinator or Data Team Lead (with guidance). Perform comprehensive data management tasks including data review, writing and resolving data clarifications. Perform database designer activities for technologies not requiring extensive programming. Perform comprehensive quality control procedures. Independently bring project solutions to the CDM team. Solve issues through using the global issue escalation/communication plan. Consult with Standards Group for process issues; communicate ideas for process improvement. Assist in developing and implementing new technology. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team. Interact with CDM team members to negotiate timelines and responsibilities. -
Clinical Data CoordinatorQuintiles Oct 2013 - Mar 2015Bengaluru Area, IndiaTherapeutic Area: Oncology/Hematology/Transplantation Serve as a Data Operations Coordinator (DOC) for one or more protocols with less than 5 operations staff (excludes DE) or a leadership role in a specific area or process on a large study with guidance. Serve in the role of back-up to a Data Operations Coordinator. Conduct data review. Write and resolve data clarification. Develop and test databases and edit specifications. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team. Mentoring new team members on specific project tasks. Assign Monthly listings/ reconciliation tasks to team members and ensure study activities are documented promptly in the electronic repository. Ensure all team members have completed mandatory trainings, before gaining access to systems and revoking access as appropriate. Responsible for maintenance of study file with all relevant study documentation, audit-ready at anytime. Responsible for Identification and documentation of process non-compliance/ Protocol deviation. Ensure 85% Utilization on project-related activities. Meet defined Productivity >90%. Meet Query Quality Index of <1% on the Study Level QR, DOC Level QR and Employee level QR for all the process groups. Actively share and build knowledge between self, team members and other departments. Predefined & Manual Triggers to be raised as per the process specified timelines & Daily review of the shared mail box & communication log. Overall TAT to be met for all projects. Project Deliverable Timelines / milestone / Project Plan to be met for all projects for >95% of time.
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Associate Clinical Data CoordinatorQuintiles May 2012 - Oct 2013Bengaluru Area, IndiaMy therapeutic areas of expertise is: Hematology / Oncology / Transplantation Conduct basic data review. Write data clarifications. Resolve data clarifications. Conduct basic quality control procedures. Meet personal project objectives, as assigned by manager. Escalate problems to the attention of the Data Operations Coordinator or Group Manager. Understand and comply with core operating procedures and working instructions. Understand, provide input to and comply with all applicable sections of Data Management Plan. Understand basic database structures. Develop and maintain good communications and working relationships with CDM team.
Swapnil Thorat Skills
Swapnil Thorat Education Details
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Project Management -
Psychology -
Pgd In Clinical Research And Clinical Data Management
Frequently Asked Questions about Swapnil Thorat
What company does Swapnil Thorat work for?
Swapnil Thorat works for Novartis
What is Swapnil Thorat's role at the current company?
Swapnil Thorat's current role is Senior Principal Clinical Data Scientist (Senior Program Data Manager)Experienced Clinical Data Manager and Agile Leader, fostering innovation and collaboration to elevate data management practices in healthcare..
What is Swapnil Thorat's email address?
Swapnil Thorat's email address is sw****@****ail.com
What schools did Swapnil Thorat attend?
Swapnil Thorat attended Indian Institute Of Management Rohtak, Sikkim Manipal University (Smu), Southern New Hampshire University, University Of Mysore, Punyashlok Ahilyadevi Holkar Solapur University, Solapur, Jawahar Navodaya Vidyalaya (Jnv).
What skills is Swapnil Thorat known for?
Swapnil Thorat has skills like Clinical Trials, Clinical Data Management, Good Clinical Practice, Molecular Biology, Lifesciences, Cro, Ich Gcp, Inform, Life Sciences, Pharmaceutical Industry, Microbiology, Clinical Research.
Who are Swapnil Thorat's colleagues?
Swapnil Thorat's colleagues are Joshua Chambers, Ramon Toma, Abdula Husam, Dorina Ivan, Yiqun Yang, Marina Kosova, Lilian Machado De Souza.
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