Prajakta Ajgaonkar
Senior Principal Data Standards Specialist @Novartis India
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WORK HISTORY
Senior Principal Data Standards Specialist @Novartis India
IN
EDUCATION
University of Mumbai
M.Sc.
SKILLS
ABOUT PRAJAKTA AJGAONKAR
A professional with 16 years of experience in various domains of clinical data management, client management, along with project management and quality management.Possess solution oriented, quality conscious, flexible attitude and in-depth progressive experience in the areas of clinical data management.Experience in all phases of Clinical trials, end to end experience of Paper & EDC trials and wide range of therapeutic areas.Worked on CDMS like OC, OC-RDC, InForm, WebSys, Rave and tools like Oracle Discoverer, I-Review, J-Review, e-filing software like CRF WorkManager.In depth knowledge of CRF designing, database design specifications, data entry, data Validation, UAT, Safety and TPD reconciliation, creating and maintaining various guidelines within Data management plan, SDTM review, quality control and quality assurance process.Expertise in vendor management - central labs, IVRS, CRF printingCoordination between various teams, including DM, clinical, biostatistics, medical monitors, QC, safety, both internal as well as from the sponsor\'s side.Effective communication skills when working with project teams, internal & external customers,to maintain understanding and ownership within cross-functional team.Involved in project management activities such as project tracking, preparation and maintenance of metrics, quality checks, resources planning.Actively handled defect prevention teams, calibration activities.Providing quality assurance, compliance with all applicable SOPs, ensuring deliverable meet highest level of quality and within timeline.Training - Involved in imparting training to team members that includes CDM and quality processes, project specific and tool specific training like CRF WorkManagerSpecialties:Project Management, Leading data Management and quality teamGood understanding of budgetary aspects of project End to end Data Management activitiesMentoring team membersGood understanding of ICH-GCP, ethics & other CDM concepts
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