Study Start Up Specialist

1 month ago

Sydney, Australia Novo Nordisk AS Full time

Are you seeking a contract role in Study Start-Up? Would you like to be involved in planning and 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? If so, keep reading – we may have just the right job for you Novo Nordisk Australia has opened a role for a Study Start-Up Specialist (SSUS). Join us and apply today
 

About the department
Novo Nordisk has been globally recognized as the Best Place to Work, topping the ranks for two consecutive years in 2022 and 2023. It is an exciting time to join Novo Nordisk and be part of a dynamic company in an even more dynamic industry, helping us achieve our aspirations to establish a global presence in the industry.
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 SSUS is involved from site selection to site activation, driving the rapid start-up of clinical trial sites. Reporting to the SSU Clinical Research Manager in the Clinical Development Centre (CDC) Oceania, you will be 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 conducted 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 and collaboration both internally and externally to reduce site activation timelines. Proactively identifying any risks in SSU and site activation plans to relevant stakeholders, and developing and implementing mitigation strategies as required. Prepares relevant handover documentation to allow TMs and CRAs to effectively manage ongoing and amendment submissions post site activation.  Ensure that Site Initiation Visits are ready to be scheduled and that site activation documentation is on track as per approved 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 the regulatory approval process in Australia, confirmed with a minimum of 2 years of working experience in clinical research in any applicable function. Good knowledge of clinical trial methodology, along with up-to-date knowledge of the clinical trials environment, including ICH GCP, regulatory issues, and Standard Operating Procedures (SOPs). Good presentation skills, negotiation abilities, and basic legal experience are desirable. Computer literacy and IT skills, including proficiency in Microsoft Office (Word, Excel, and PowerPoint), as well as experience with a variety of internal and external IT systems (e.g., Sponsor Trial Management System (CTMS), Electronic Trial Master File (eTMF), ERM, HREA, Coupa, novoTime).

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