766 million patients were reached with Novartis medicines.
We aspire to get Novartis medicines in the hands and homes of patients by delivering a Triple Win: A Win for Patients; A Win for Healthcare Systems, and A Win for Novartis.
The Clinical Site Associate performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Hematology clinical trials within the country.
The Clinical Site Associate 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.
Your responsibilities include, but are not limited to:Trial Monitoring strategyConducts feasibility and screen potential Investigators and networks to evaluate capabilities for conducting clinical trialsAllocation, initiation and conduct of trialsConducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial.
Recommends sites to participate in clinical trialIs the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveriesManages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and Novartis proceduresFacilitates the preparation and collection of site and country level documentsPerforms 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 appropriateConducts 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 safetyIs accountable for continuously updating all electronic systems (global and local) relevant to perform job functionsEnsures 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 requirementsAttends onboarding, disease indication and project specific training and general CRA training as requiredDocuments monitoring activities appropriately following Novartis standardsCollaborates with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans, as neededParticipates from audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelinesPerforms additional task as assigned Delivery of quality data and compliance to quality standardsMonitors studies as per current legislations, ICH/GCP and Novartis standardsInvolved in Site Excellence initiative and Cross-Functional activities, as Site Ambassador, with a holistic view of the sites, promoting the direct contact due to a regionalized modelIs the frontline liaison to ensure successful collaboration and to facilitate communication between sites and Novartis CPOEnsures to increase the engagement with sites and leverage interaction level with other stakeholders, such as medical department, MSL or Market AccessCommitment to Diversity & Inclusion:Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum requirements:What you'll bring to the role:Education: Degree in scientific or healthcare disciplineLanguages: Fluent in both written and spoken English and Spanish, as needed in clusters/countriesExperience: Minimum of 3 years experience in site monitoringExcellent knowledge of the drug development process specifically clinical trial/researchKnowledge of international standards (GCP/ICH, FDA, EMEA)Ability to manage multiple priorities and manage time efficientlyBasic project management skills to support in CSM activitiesAbility to travel domestically (and possibly internationally) as needed to study sites and for training and meetingsA minimum of 50% overnight travel may be requiredAdvanced communication skills, ability to influence othersGood strategic thinking: Ability to anticipate potential issues and take appropriate actions with or without supervisionAdvanced data accuracy: Ability to work focused with a great attention to detailAbility to manage sites independently; Proven ability to work independently with or without minimal supervision by directYou'll receive:Company Pension Plan; Life and Accidental Insurance; Meals Allowance or Canteen in the office; Flexib
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