Local Trial Managers

Career Category

Clinical

**Job Description**:
HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Live - What you will do- Remote/Work From Home - based in Sydney, Melbourne, Brisbane, Perth or Adelaide- Join a diverse & inclusive community of belonging

Let’s do this. Let’s change the world. In this vital role you will be the primary point of contact to lead, manage and co-ordinate clinical trials from study start-up to close out (CSR/Archival) at country level in accordance with ICH-GCP and other applicable local regulations. You will maintain the quality and scientific integrity of clinical trials at a local/country level and actively collaborate with cross functional internal and external partners to ensure timely delivery, budget implementation of clinical trial results within the local country.

Key Activities:
- Partner with global and local country teams to provide high level country strategy and actively drive study progress and local/country level study delivery- Planning, management and oversight of clinical study implementation in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study Team- Communicate country status (including timelines and results) to key partners including updates to relevant systems for transparency- Provides country level input into the Country Operational Plan and partners with the Development Feasibility Manager through feasibility and with the Global Clinical Managers to ensure local delivery of the study- Support internal audit and inspection activities and contribute to CAPAs, including leading resolution of issues when appropriate e.g., vendor management- Assign and deliver all study support staff and continually review country level risk mitigation to ensure study delivers to plan

Win - What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Trial Manager with these qualifications and experience.- Relevant tertiary qualifications- Experience in local clinical trial management in a biotech, pharmaceutical or CRO company- Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)- Proven local Project management including oversight of quality, study deliverables, budgets and timelines- Proven ability to build strong site relationships as well as other local stakeholders ensuring end-to-end study delivery- Fluency in English, both oral and written communication- Residency and permission to work in Australia is essential

Thrive - Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act- Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

To find out more about the Amgen Difference - Our People and our Value, check out this link:
At Amgen we are committed to doing everything we can to deliver for patients, to keep our staff and their families safe, and to help the communities where we live and work reduce the number of people exposed to COVID-19. As a science-based company, we strongly believe that it is our role to lead the way and therefore it is a requirement that all Amgen Australia employees must be fully vaccinated (certain exemptions will be considered on a case-by-case basis).

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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Objects in your future are closer than they appear. Join us.

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