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    Team Member - Mumbai, India - Cipla

    Cipla
    Cipla Mumbai, India

    5 days ago

    Default job background
    Full time Pharmaceutical / Bio-tech
    Description

    Key Responsibilities:

    • Identify Investigators/ CRO; conduct feasibility & site selection, site Initiation, Co-monitoring visits for site for PK in patient (early phase studies)
    • CRO & multiple study vendor evaluations till selection as per Cipla process
    • Conducting Top-line & detailed feasibility by coordinating with multiple CRO vendors within timelines. Preparing feasibility report & proposals comparison, coming with most suitable time/cost estimate as part of new product development process – for different indications & study designs.
    • Preparation, review, and compilation of study documents.
    • Ensuring proper compliance of the documents with the regulatory guidelines.
    • Planning and coordination of investigators meetings (IM); preparation and review of IM material.
    • Training to site coordinators; coordination with the sites and CROs to conduct the study as per the protocol and Standard Operating procedures (SOPs) that meet the regulatory guidelines.
    • Co-ordination for IMP requirements for study conduct and related documents
    • Conducting Monitoring visits to ensure study compliance. (Approx. 50-60% travel may be required.
    • Travel % may vary project to project.)
    • End to end project management starting from CRO/ Vendor selection till study CSR submission till regulatory.
    • Providing end to end Project management support throughout the study cycle till study approval.
    • Ensuring timely, accurate, complete collection and submission of study data starting from feasibility till CSR submission to regulatory.
    • Cross functional co-ordination across multiple dept within Cipla (Project management, regulatory, R&D, QA, Finance, GSS and legal) for multiple activities / approvals to be coordinated for smooth running of study
    • Coordination of 505 b (2) products development and active involvement
    • Coordination in biosimilar development program
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