Ashwini Lambe Email & Phone Number

-Healthcare professional with 7+ years of experience in Clinical Data Management with Study Initiation, Conduct and Closeout in therapeutic areas like: Oncology, Neurology, Immunology, Ophthalmology, Cardiology etc.-Competency at working on all three phases ( I, II, III) of study.-Review study protocol, Coordinate with Sponsor, Develop eCRF specification, eCRF Completion Guidelines, Data Management Plan (DMP), Edit Check Specifications, Data Coding Plan, Data Review Guidelines, Annotated eCRF Specification.-Design and developing eCRF forms, conducting unit testing and releasing to the Quality Assurance team.-Proficient knowledge in complete Clinical Trial Management System (CTMS), FDA Regulations (CFR 21 Part 11), ICH Guidelines and Good Clinical Practice (GCP).-Knowledge and understanding of regulations and industry-adopted data standards, such as CDISC SDTM, ADaM and CDASH.-Expert in Coordinating cross functional teams such as Sites, Clinical Operations Team, Programmers, Medical Coders, Vendors for Reconciliation Issues to ensure timely completion of deliverables.-Proficient with handling multiple studies at a time and ability to plan, manage & work efficiently in both independent and collaborative environments.-Experience using commercial clinical data management and/or EDC products (Medidata Rave, Oracle Clinical, InForm).-Hands-on experience on various Clinical Tools like HP ALM, iMedidata Coder tool, Jarvis, Smartsheet, Veeva Vault. -Experience in Medical Coding (MedDRA and WHO DD).-Worked on various Reconciliation Reports (SAE, PK Sample, LAB and ECG).

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  Pune University

  Bachelor Of Pharmacy