Praneeth Patlola
This listing was posted on Willhire.
Biomarker Scientific Monitor & Study Coordinator (Sr. Scientist II)
Location:
Basel
Description:
<p><strong>This is a temporary contractor opportunity at Novartis</strong></p><p>Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!</p><p>Novartis partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com</p><p>Ready to work with/through Magnit at Novartis? Please read on...</p><p>As Biomarker Scientific Monitor & Study Coordinator (Sr. Scientist II) your daily tasks and responsibilities will include but not be limited to the following:</p><ul><li>Develop and provide operational reviews of global clinical study protocols, site operations manuals, informed consent forms, sample collection table, instruction manual, central lab protocol/manual, and eCRF and other biomarker sample logistics including study startup/setup, sample tracking/reconciliation, assay set up and sample/data upload. You may also serve as a SME in one more operational areas.</li><li>Independently place, set up, implement and monitor “fit for purpose” complex biomarker assays at external service providers (ESP) in one or several biomarker modalities (e.g, Imaging, Tissue Biomarker, Immunoassay, etc .) in TM clinical studies. You may also serve as a Subject Matter Expert (SME) in one of the biomarker modalities.</li><li>Support data transfer and data flow in LIMS and DTS (e.g., study creation, data flow, data transfer, etc.) for managed biomarkers and studies. Update study and project information in relevant IT systems.</li><li>Ensure quality and compliance of global external service provider (ESP) and their deliverables.</li><li>Identify, escalate and resolve complex assay troubleshooting, sample management or ESP issues, quality or performance issues and engage LF experts, clinical trial leaders and data management as needed.</li><li>Collaborate with other TM and BMD functions and lead clinical site processes, continuous improvement initiatives and innovations in LEO.</li></ul><p><strong>Minimum requirements:</strong></p><ul><li>BS in life science with 5+ years of experiences or advance degree with 2 years in clinical operations and/or clinical bioanalysis as well as training/experiences in global clinical study operation, clinical imaging and vendor management and/or laboratory.</li><li>Strong scientific knowledge of global study start up, clinical operations, clinical sample analysis and management of external service provider (ESP).</li><li>Proven track record of independent contributions to global clinical studies and clinical operations is required.</li><li>Experience working with ESP and monitoring biomarker work at external service providers (ESP) and data flows (LIMS, DTS, etc.).</li><li>Method development and troubleshooting experiences for complex bioanalytical and biomarker assays.</li><li>Knowledge of the drug development process and regulatory requirements e.g., GCP, GLP, etc.</li><li>Strong global project management, problem solving, influencing, communication and leadership skills.</li><li>Fluent in English as working language.</li></ul><p><strong>Desirable:</strong></p><ul><li>Understanding of central lab operations.</li><li>Laboratory knowledge and subject matter expertise in one or more technologies (e.g., Immunoassay, Imaging, Tissue Biomarker, etc.) is strongly preferred.</li></ul><p><strong>Role type: Onsite<br />Workload: 40 hours/week</strong></p><p><strong>Why Novartis: </strong>Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture<br /><br /><strong>Commitment to Diversity and Inclusion / EEO:</strong> Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.<br /><br /><strong>Join our Novartis Network: </strong>If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network<br /><br /><strong>Accommodation: </strong>If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at XXXX@prounlimited.com</p>
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