Opening for the post of Clinical Data Manager @ Novartis
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Our mission is to care and cure. We want to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering and to enhance the quality of life.Novartis has five business segments and is supported by our global research organization, the Novartis Institutes for BioMedical Research (NIBR). These segments are strategically aligned to bring innovative, high-quality and affordable medicines and therapies to patients around the world. We strive to provide our associates with the safest possible workplace and to promote their health and well-being. We are an integral part of the communities that host our operations. We pay living wages worldwide, contributing to the stability and prosperity of these communities

Job Title : Lead-clinical Data Manager- SR

Qualification : B.sc/M.sc Life Science/Clinical Research

Job Description :

     Serve as Project Data Manager for multiple projects/trialsvfrom 1-2 business units (BUs) and providing professional Data Management input to Clinical Trial Teams (CTTs) and CPOs as needed.
     Responsible for ensuring consistency of protocols, project CRFs, clinical databases for all trials within assigned projects and provide technical feedback to CROs as needed.
    Monitor clinical data quality and progress of trials outsourced to international CROs; drive corrective actions as needed; ensure proper integration of third-party/non-CRF data as applicable.

    Proactively identify project threats and resolve issues with clinical trial teams; escalate to CDS management if necessary and appropriate.
    Ensure up-to-date and accurate tracking of report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases.
    Ensure timely completion of data management archiving; as necessary; respond to Health Authority/FDA/audit requests pertaining to project-specific data management issues.
    Provide input, review, and maintenance of local working practices and standards. 

Experience : 1-5 years

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