Jigneshkumar P.
Manager, Clinical Data Standards @TAKEDA PHARMACEUTICALS AMERICA, INC.
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WORK HISTORY
Manager, Clinical Data Standards @TAKEDA PHARMACEUTICALS AMERICA, INC.
Reviewed Protocols and provided feedback from the Standards and Data Management perspective. •Analyzed and led cross-functional meetings to propose existing eCRF specs reusability from library per therapeutic area and eCRF specs used for earlier sister studies.•Designed and developed new eCRF specifications based the clinical study protocol and /or updated existing eCRF specifications as needed and coordinated the review/feedback from all stakeholders.•Focused on staying compliant with CDASH standards while designing or updating eCRF specification.•Scheduled and led internal Standards meetings to discuss which updates qualify for the library upgrade among the all the updates in various documents/forms like eCRF specs, SDTM mapping specs, SDTM metadata, work instructions, SOPs and other overview documents.•Maintained library with standard forms, specifications aligning with current CDISC (CDASH, SDTM, ADaM) Standard and managed quarterly library version upgrades and release activities.•Proactively worked with all functional teams and stakeholders to get their feedback on proposed updates in various forms/specs/documents and discuss in governance meetings with other functional leads.•Led technology upgrade projects such as implementation of Veeva CDB and work with external SMEs and internal functional team leads to ensure smooth implementation.•Worked collaboratively to build database to meet the Database Go-Live timeline.•Generated Data Import Agreement (DIA) and Data Transfer Specifications (DTS) for the data coming for external/third party source.•Developed work instructions and process documents ex: Process for eCRF spec updates, codelist updates, edit-check programming, Use Acceptance Testing (UAT) and overview documents.•Ensured communication, coordination and collaboration among Data Management staff, Standards team as well as other functional teams within and outside of the organization globally.
EDUCATION
Sardar Patel University
Bachelor of Engineering (B.E.)
Kalapi Computers
Programming
SAS Institure
SAS Certified Base Programmer for SAS 9
ABOUT JIGNESHKUMAR P.
Clinical data management professional with over 8 years of experience in Clinical Research Organizations and Pharmaceutical Company. Proven proficiency in administering all facets of clinical data management, from study initiation to closure. Experiential knowledge in multiple therapeutic areas, including Oncology, Cardiology, Infectious Disease, COVID-19 Vaccine and respiratory medical device. Committed to ensuring that clinical data are accurate, complete and compliant. Capable of deriving success through meticulous attention to details and effective cross-functional team collaboration.
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