Country Study Start Up Specialist

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [www.abbvie.com](http://www.abbvie.com/). Follow @abbvie on [LinkedIn,](https://www.linkedin.com/company/abbvie/) [Facebook](https://www.facebook.com/AbbVieGlobal/), [Instagram](https://www.instagram.com/abbvie/), [X](https://twitter.com/abbvie) and [YouTube.](https://www.youtube.com/user/AbbVie)

Job Description

Turn study plans into active clinical trial sites, and help bring new medicines closer to patients.

We’re looking for a proactive Country Study Start Up Specialist to take ownership of the critical activities that move clinical studies from planning through to site activation in Australia.

Working across studies and sites, you’ll be at the centre of the start-up process, coordinating ethics submissions, essential documentation, informed consent materials and site activation requirements while partnering with Clinical Operations, Regulatory Affairs, Contracts, CRAs and regional and global Study Start Up teams. You’ll anticipate roadblocks, bring the right people together and help keep studies progressing on time and to a high standard.

This is an opportunity for someone with clinical research, study start-up, site activation or regulatory submissions experience who enjoys solving problems, managing competing priorities and seeing their work translate into sites becoming ready to enrol patients.

KEY DUTIES AND RESPONSIBILITIES

• Ensure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope primarily central IRB/EC sites. Establish the
• country/site activation plans and priorities including risk assessment and mitigation plans with CCOM/COM, Area SSU and CSM Lead, Contract Manager, CTS/Regulatory Affairs.
• Proactively identify and communicate issues impacting delivery and providing proposed solutions
• Attend regional/area start up calls and providing input for assigned sites/studies. Collection of essential documents from sites and completing quality check (ALCOA).
• Compile and submit ethics and other required local submissions including customization of ICFs, patient facing materials and safety reporting. Coordinate with Regulatory and CTS on CA submission and approval status to assure alignment w...

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