Ch Shanthipriya
Lead Clinical Data Manager @Daiichi Sankyo US
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WORK HISTORY
Lead Clinical Data Manager @Daiichi Sankyo US
NJ, US
Serves as data management lead interacting directly with sponsor, sites and vendors on EDC projects and performs all data management activities such as data collection and entry, database access requirement implementation, project specific training, and/or other tasks associated with the clinical trial database. Oversees ongoing support to electronic case report form (eCRF) systems (e.g. Inform, etc.), external data acquisitions, reporting/business intelligence tools (e.g. Spotfire, J‐Review), and other programs (e.g. SQL ). Convey specs with study team, collect input, design/program forms/dynamics checks for the study in Rave. Perform unit testing, share EDC screen and walk-through forms/design, and update as needed. Have understanding about UAT/testing documentation and approval process. Managing the processes to ensure data integrity via appropriate data management processes, such as manual data listing reviews, query review and generation for missing or discrepant data, evaluating data outliers, performing data or query quality checks, ensuring database updates are applied, etc.) in accordance with approved study documentation. Act as a primary contact for sites or other study team members if there are questions regarding data management issues for their assigned trial. Proactively performs data management study startup activities including CRF/eCRF design, CRF annotation, developing database specifications, and defining validation specifications, and database and validation specification testing Participates in internal/sponsor meetings and training programs, as required, working directly with the assigned project manager to provide data management support. Involving in the meetings and provide formal training as required. Performs Business Development functions including but not limited to attendance and participation in client meetings.
EDUCATION
MNR College of Pharmacy
Master's degree, Pharmacy
ABOUT CH SHANTHIPRIYA
Strong and comprehensive clinical data management skills in study set-up, Conduct and close-out activities. Experienced in working with different phases of Clinical Trial from Phase 1-3. Extensive experience in designing eCRF Specifications, edit checks specifications, User acceptance testing (UAT), Lab Reconciliation, external vendor data reconciliation, Data Cleaning, and discrepancy management. Proficient in working with EDC trials and understanding of industry standards including ICH-GCP guidelines, GCDMP, and 21 CFR Part 11. Worked comprehensively on a wide range of EDC Databases – Veeva vault, Medidata Rave and InForm to perform Query Management and other data management tasks. Documented data via Data Management Plans (DMP) following Standard Operating Procedures (SOP), Good Clinical Practices (GCP), and Organization regulations Extensive knowledge of CDASH and CDISC standards and applications. Proficient in Team management, Vendor Management, Client Interaction, and communication within different departments of the Clinical research domain. Collaborated with members of other functional teams (Biostatistics, Clinical Operations, Safety Surveillance), Vendors (Clinical & DM CROs, Labs) regarding the project and related issues. Experienced in various therapeutic areas such as Respiratory, Gastroenterology, Hematology, Endocrinology, Cardiology, Oncology, Rare disease etc. Mentored Junior DM staff, prioritized their assigned tasks, and helped with the completion of their tasks. A quick learner with an eye for detail with strong leadership skills. Good communication, written, and Verbal skills. Well-organized, high attention to detail and degree of accuracy, and proficiency in Multitasking. Have good experience in Medidata Rave database design with ALS and Edit Checks creation with performing UAT.
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