Study Start Up Specialist

**About the department**
Novo Nordisk is a global healthcare company with nearly 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 Senior SSU CRA is involved from site selection to site activation. You will take the leadership in formulating the optimised submission strategies with the aim of reducing the number of required submissions and approval timeframes.
Reporting to the Operational Excellence & Quality Manager in Clinical Development Centre (CDC) Oceania, you will lead in managing and executing the 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 and New Zealand.

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 negotiates with trial sites including finalisation of Clinical Trial Research Agreements and Indemnities
- Build and maintain close relations and collaborations with all Novo Nordisk CDC staff within Oceania to ensure optimal trial delivery, specifically working towards key startup KPI of 80% site activated at country First Patient First Visit (FPFV) for trials in the CDC and adjacent
- 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. Also, need to adapt to the changes to the approval process and incorporate into Novo Nordisk processes
- 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**
- Degree or equivalent in life science, medical or pharmacy is essential
- Solid knowledge of clinical trials ethics and regulatory approval process in Australia and New Zealand, confirmed as a minimum of 2 years working in clinical research in any applicable function
- Good knowledge of clinical trial methodology along with up-to-date knowledge of the clinical trials environment - ICH GCP, regulatory issues, Standard Operating Procedures (SOP’s)
- Good presentation skills with negotiation and basic legal experience (desirable)
- Computer literacy and IT skills including Microsoft Office, Word, Excel & PowerPoint. Also, usage of a variety of internal and external IT systems e.g., Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), ERM, HREA, Coupa, novoTime

**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**

**Deadline**

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

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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