The 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 CRA is responsible to deliver data within timelines and required quality standard, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
Your responsibilities include, but not limited to :
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
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
What you’ll bring to the role :
Degree in scientific or healthcare discipline
Fluent in both written and spoken English, local language as needed in clusters / countries
Up to 2 years pharmaceutical industry experience or other relevant experience
You’ll receive :
Competitive salary, annual bonus, pension scheme, share scheme, health insurance, 25 days annual leave, flexible working arrangements, subsidized dining facilities, employee recognition scheme.
927 million. That’s how many lives our products touched in 2017. 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.
Join us and help us reimagine medicine.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
We kindly ask you to apply with an English version of your CV and if shortlisted you can expect a call from an international number.