CRA - Study Start Up
Novo NordiskNorth Sydney, New, AUAre you seeking a contract role in Study Start Up? Would you like to be involved in planning & executing the Study Start-Up activities in the allocated clinical trials? Do you want to be part of a dynamic team, working in an international environment that drives clinical trial activities? Then keep reading – we may have just the right job for you! Novo Nordisk Australia has opened a 12-month contract role for a CRA - Study Start Up. Join us and apply today!
About the department
Novo Nordisk is a global healthcare company with over 100 years of innovation and supervision in diabetes care.
The Novo Nordisk Oceania affiliate is a high performing and growing organisation operating within a dynamic healthcare environment across Australia and New Zealand. Our primary therapy areas are diabetes and obesity, and we offer a broad range of medicines within the areas of haemophilia, growth disorders and women’s health.
The position
The CRA - Study Start Up is involved from site selection to site activation, driving fast start up of clinical trial sites. Reporting to the SSU Clinical Research Manager in Clinical Development Centre (CDC) Oceania, you will be executing the Study Start Up (SSU) activities in the allocated clinical trials in compliance with local regulations, ICH-GCP (Good Clinical Practice), Novo Nordisk procedures and protocol requirements for studies placed in Australia.
This position requires :
- Mapping of SSU strategy for each site, assigning lead sites as applicable and planning approval timelines in consultation with Trial Managers (TMs). Also, involved in the preparation of study budgets in consultation with TMs and negotiating with trial sites including finalisation of Clinical Trial Research Agreements and Indemnities
- Building and maintaining effective relationship management & collaboration both internally and externally to reduce site activation timelines.
- Proactively identifies any risks in SSU and site activation plans to relevant stakeholders, develops and implements mitigation strategies as required.
- Prepares relevant handover documentation to allow TMs and CRAs to effectively manage ongoing and amendment submissions post site activation.
- Ensure Site Initiation Visits are ready to be scheduled and site activation documentation is on track as per agreed timelines with the TM and in collaboration with the assigned CRA.
Qualifications
Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and difficulties. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can live a life free of chronic disease.
Contact
Upload your CV to our online career page (click on Apply and follow the instructions).
Deadline
We will review applications as they are received so don’t hesitate to apply!
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. First Nations peoples are encouraged to apply.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
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