769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.
The Senior Imaging Operations Manager will be responsible for the operational implementation of the imaging strategy for assigned clinical studies in collaboration with the clinical trial team (CTT). Accountable for the timely operational execution of the protocol specified imaging components, in compliance with Novartis processes and regulatory requirements.
Your responsibilities include, but not limited to: * Support individual clinical trial teams (CTTs) for all imaging-related matters for assigned studies. Attend Clinical Trial Team and other trial meetings as applicable. * Prepare Imaging Study Specifications Worksheet (ISSW) to negotiate and manage requirements and costs with CROs. * Provide input on imaging sections in clinical trial-related documents (such as protocols and consents) with guidance of Medical Lead and (associate) Global Trial Director. * Manage the imaging CRO interface with the CTT, including leading the imaging CRO meetings. Contribute to the preparation and review of key documents, including imaging manual, imaging charter, data transfer specifications, etc. * In collaboration with the imaging CRO, the CTT, and GDO Trial Monitoring, support the tracking and collection of missing scans. * Track and ensure adherence of imaging CRO to critical imaging related milestones, including the timely delivery and quality of central review results as applicable. * In collaboration with the CTT and with the imaging CRO, define imaging needs for the case report forms and data transfer. With support, liaise with the trial data manager and imaging CRO for data transfer, data reconciliation, and querying as needed. * In partnership with imaging CRO, develop site and monitor training material. May also be involved in training of monitors and site personnel. * Contribute to imaging excellence by providing training to CTTs on trial imaging related aspects and contributing to the standardization of documents.