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The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials within the country.
The Senior CRA is responsible to deliver data within timelines and required quality standard, and for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
Major Accountabilities (Describe the 5-7 main results of the role to be achieved)
Trial Monitoring strategy * Conducts feasibility and screen potential Investigators and networks to evaluate capabilities for conducting clinical trials Allocation, initiation and conduct of trials * Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial * Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries * Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures * Facilitates the preparation and collection of site and country level documents * Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Retrains site personnel as appropriate * Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety * Is accountable for continuously updating all electronic systems (global and local) relevant to perform job functions * Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.) * Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements * Attends onboarding-, disease indication and project specific training and general CRA training as required * Documents monitoring activities appropriately following Novartis standards * Collaborates with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans, as needed * Participates from audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines * Performs additional task as assigned Delivery of quality data and compliance to quality standards * Monitors studies as per current legislations, ICH/GCP and Novartis standards * Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring. (ADIS, DBL) * Identifies issues at sites; resolves issues and escalate as appropriate * Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry * Ensures the site Investigator Folder is up to date. Is responsible for collecting essential documents from site and accountable to keep sTMF(s) current. * Participates in multi-disciplinary teams within CPO and globally to evaluate and implement process improvement * Supports the implementation of innovative processes and technologies Budget and productivity * Negotiates investigator remuneration; prepares financial contracts between Novartis and investigational sites and investigators. Ensures that payments are appropriately triggered to investigational sites
Key Performance Indicators (Indicate how performance for this role will be measured)
1. Achieves study milestones including study start-up and recruitment timelines for sites assigned 2. Delivers high quality data according to agreed timelines following global and local Novartis SOP standards 3. Quality and timeliness of data in: Novartis electronic systems, monitoring reports, and communication efforts as defined by global KPIs and KQIs 4. Deliver customer satisfaction results for internal and external customers, as applicable 5. Local individual KPIs as determined by CPO management