Job Description
This role is based in various cities across Australia. We are unable to offer relocation support for this role, so please only apply if this location is accessible for you.
You will be part of a dynamic team at the forefront of transforming patient care through trials. Your main responsibility will be to ensure sustainable trial execution at site. You will perform on-site and remote monitoring activities related to initiation, conduct, and timely completion of Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes according to ICH/GCP, local regulations, and SOPs.
You will also be responsible for proactive site performance management (recruitment & quality) and early identification of real site needs and issues as the single best point of contact (internally & externally) for all sites.
Main Responsibilities
* Frontline liaison between Novartis and sites to ensure successful collaboration, meeting milestones and deliverables with a true ownership mindset.
* Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and our procedures.
* Performs Site Initiation Visit, ensures site personnel is fully trained on all trial-related aspects.
* Conducts continuous training for amendments and new site personnel as required.
* Re-trains site personnel as appropriate.
* Conducts continuous site monitoring activities.
* Implements site management activities to ensure compliance with protocol.
* Identifies deficiencies in site processes and monitor site processes performed outside the site, works in close collaboration with site on risks mitigation and process improvements.
Required Skills and Qualifications
* Degree in scientific or healthcare discipline.
* Up to 2 years pharmaceutical industry experience or other relevant experience.
* Central/in-house monitoring or field monitoring experience is desirable.
* Decision capability, excellent time management, organization, and risk-based mindset.
* Early adopter and open mindset across borders to support one study approach.
* Good knowledge of drug development process.
* Clinical and therapeutic knowledge.
* Knowledge of international standards (GCP/ICH, FDA, EMA).
* Understanding the purpose of the CRA.
* Fast change adaptability to best partner & influencing with sites on fast-changing landscape.
* Trust and rapport building.
* Ability to travel domestically. A minimum of 50% overnight travel may be required.
Benefits
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We believe that everyone deserves equal opportunities, regardless of their background, abilities, or experiences. Our company values innovation, collaboration, and accountability, and we strive to create a culture that reflects these values.
Why Join Us?
At our organization, we believe that everyone has the potential to make a meaningful contribution. We are dedicated to creating a workplace that is inclusive, supportive, and empowering. If you share our passion for transforming patient care and want to join a talented team of professionals who are shaping the future of healthcare, we encourage you to apply for this exciting opportunity.