Se necesita Monitor Senior CRA II
Have you ever imagined how does your work impacts society and how many lives can you improve through your daily activities?
1 million is the number of patients that Novartis Worldwide touched in 2018. Have you ever imagined how does your work impacts society and how many lives can you improve through your daily activities?
Central point of communication/contact between Novartis and the Investigator and Investiga-tional site personnel to ensure:
• That all trial related activities are conducted at site following GCP and Novartis stand-ards (processes and SOPs),
• That agreed targets (e.g. number of patients, key milestones) are met The senior CRA is able to work without supervision on complex trials
Study Planning: Contribute to the identification of new sites for CT; analyze capability and support CRMA and CSM in making recommendation for trial inclusion.
Assume ambassadorial role to facilitate communication between sites and NVS CPO to increase value proposition to investigators.
Facilitate the preparation and collection of site and country level doc.
Negotiate investigator remuneration; prepare financial contracts between Novartis and investigational sites and investigators.
Ensure adherence to payment schedule.
Participate in the review of the monitoring plans.
Provide input regarding the protocol, feasibility and amendments.
Provide input regarding monitoring strategies
Study Start-up: Assist CRMA with protocol training and logistics for local CRAs.
Facilitate, standardize and coordinate CRA, cCRA and ucCRA activities across a coun-try/cluster.
Prepare and circulate site selection visit agenda with all appropriate appendices to all local CRAs.
Ensure that all local CRAs are provided with all tools necessary to conduct the trial, and work with the CSM and CTA to ensure that all necessary site tools are circulated to sites.
Prepare tools in local language in order to help sites in conducting the trial.
Attend and document investigator meeting and circulate documentation.
Collaborate with CSM to communicate trial logistics prior to local FPFV.
Prepare and circulate site initiation visit agenda to all local CRAs.
Collate and summarize questions/issues regarding protocol logistics and monitoring specifics and seek resolution with the CSM.
Execute site initiation and training, generate initiation visit report.
Study Execution.Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.
Ensures smooth operational execution of allocated clinical trials Implement complete site management including monitoring visits, reg assessment, drug supply mgm, etc. to ensure compliance with protocol,GCP,global and local regulations and processes.
Facilitate regular comm. with local CRAs, cCRAs and ucCRAs.
Support the CSM in the oversight of Country and Site TMF.
Ensure that all trial doc are adequate,of good quality and are archived per relevant SOP.
Identify problems at sites;resolve issues and escalate.
Complete preparation and generation of visit monit. reports as per relevant SOP.
Review and manage data at site;resolve technical and content issues in order to achieve timely database lock targets.
Why consider Novartis Group of Companies?
750 million. That’s how many lives our Novartis group products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help reimagine medicine.
Degree in scientific or healthcare discipline.
Master’s degree preferred.
Fluent in local language(s)
Very good written and spoken English
2 to 4 years pharmaceutical industry experience including monitoring activities
Excellent knowledge of the drug development process specifically clinical trials/research
Knowledge and experience of international standards (GCP/ICH, FDA, EMEA)
The Novartis Group of Companies seek equal opportunities and we are proud of the diversity of our teams. In this company we do not discriminate any person or social group by their nationality, language, sex, gender, age, disability, social status, indigenous identity, gender identity, physical appearance, health conditions, religion, ideologies, sexual preference or orientation, for having tattoos or any other reason that has the purpose of preventing the enjoyment and exercise of human rights.