Novartis
Location
Secunderabad | India
Job description
• Advise on current and future digital strategies for sensors, wearables and medical devices deployed in clinical studies that align with the needs of the cardiovascular and metabolic portfolio.
• Conduct up-to-date and state-of-the-art advanced data analytics on acquired digital data, both using standard statistics and contemporary machine learning approaches.
• Participate in the selection and evaluation of CROs, vendors and medical/digital device technologies, and third-party artificial intelligence algorithms that can be deployed in early phase clinical trials.
• Provide solutions with documentation, testing services as required, and supervise implementation as the QSI project lead and the activities performed by the CRO.
• Lead current and future integration of mobile medical device data into exploratory analysis plans leveraging device and sensor processed and raw data content.
• Establish a validation strategy of derived digital endpoints and generate reports during different stages of trials. Interact with internal regulatory experts to assess the appropriateness and utility of products and algorithms for application at various stages of the clinical trial portfolio.
• Participate in and lead cross-functional biomarker collaborations with Discovery and Development partners to support translational and development activities.
• Work expeditiously as a member of matrixed clinical trial teams with diverse membership and expertise.
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