Rujuta Jadhav
IRT Lead | eTMF Quality Specialist | eClinical System Analyst
- Role
- Irt Lead-global Clinical Solutions Specialist at AstraZeneca
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Rujuta Jadhav
AstraZeneca fosters impactful contributions through leadership in managing IRT systems…
Experience
Irt Lead-global Clinical Solutions Specialist
Jul 2024 — Present · Bengaluru, IN
Lead in the Oncological, R&I and CVRM studies in the phase II and (Set-up and Maintenance and Closeout).Responsible for- IRT system on a study in relation to process and system set up/ maintenance/ closure by- providing clinical input to IRT system based on CSP and consultancy with in partnership with Study - Provide necessary training and manage the GCS team and IRT users.Teams and external partners- Close collaboration with vendor representatives and study teams- supporting life cycle management and business continuity for Clinical Operations processes, systems/tools, standards, procedural documentation and training materials- eTMF set up for the study, TMF plan development, performing Quality Checks and coordinating periodic Quality Checks of Functional Representatives and Local Teams- providing periodic QC training for Functional Representatives- IMPACT set up, oversight on IMPACT compliance - administrative support, newsletters preparation, meeting minutes and reports preparation for team members- performing analyses of Clinical Operations processes and tools to define business usage and identify opportunities to improve efficiency/effectiveness of systems/methods/processes- serving as subject matter expert (SME) in IRT area- leading operational aspects of IRT system set up process to ensure system is delivered to agreed time, cost, quality and functionality- participate in the preparation of study documents- support the GSAD with budget management, for eg. COL reviews- taking apart in the reconciliation process between IRT and EDCSupporting other teams for UAT Testing – responsible for creating User Acceptance Testing documentation for IxRS system (Test Plan, Test Scripts, Test Report), review of the User Requirement Specification (to understand testing requirements) and tracking testing issues resolution observed during testing.
Education
Mount Carmel Junior College
Higher secondary education
2015 — 2017
MITCON Biotechnology and Pharmaceutical Centre
Post graduate diploma
2020 — 2021
Savitribai Phule Pune University
Bachelor's degree
2017 — 2020
Savitribai Phule Pune University
Masters
2020 — 2022
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