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Job Details
Novartis
Trial Monitoring – Expert CRA - Northeast Region (Remote)
Job Description
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.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Candidates must reside in one of these states, relocation is not offered for this role:
PA, NJ, NY, CT, RI, MA, NH, VT, ME
The Expert CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV GDD trials within the country.
The Expert 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.
Trial Monitoring strategy
• Conducts feasibility and screen potential Investigators and networks to evaluate capabilities for conducting clinical trials
• Assumes ambassadorial role to facilitate communication between sites and Novartis CPO to increase value to investigators
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
• Additionally takes on Local Lead CRA responsibilities in order to manage key programs
• Takes on the responsibility as SME (Subject Matter Expert) as needed
• 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, ensure 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/Clinical Study Manager 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 escalates 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
• Performs additional task as assigned
• Participates in or leads multi-disciplinary teams within CPO and globally to evaluate and implement process improvement
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
[Register to View]
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Candidates must reside in one of these states, relocation is not offered for this role:
PA, NJ, NY, CT, RI, MA, NH, VT, ME
The Expert CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV GDD trials within the country.
The Expert 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.
Trial Monitoring strategy
• Conducts feasibility and screen potential Investigators and networks to evaluate capabilities for conducting clinical trials
• Assumes ambassadorial role to facilitate communication between sites and Novartis CPO to increase value to investigators
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
• Additionally takes on Local Lead CRA responsibilities in order to manage key programs
• Takes on the responsibility as SME (Subject Matter Expert) as needed
• 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, ensure 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/Clinical Study Manager 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 escalates 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
• Performs additional task as assigned
• Participates in or leads multi-disciplinary teams within CPO and globally to evaluate and implement process improvement
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
[Register to View]