Local Trial Manager
Vor 7 Tagen
Clinical Development
Job Description:
HOW MIGHT YOU DEFY IMAGINATION?
You've earned your degree.
How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have.
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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.Local Trial Manager (LTM)
Live
What you will do
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 the conduct of clinical trials from study start-up to close out (CSR/Archival) at a 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 crossfunctional 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
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.
Minimum Requirements- Doctorate degree OR- Master's degree & 3 years of directly related experience OR- Bachelor's degree & 5 years of directly related experience OR- Associate's degree & 10 years of directly related experience OR- High school diploma / GED & 12 years of directly related experience- Advanced knowledge of global clinical trial management- Fluency in German and business English
Preferred Requirements- BA/BS/BSc- Minimum 2-3 years' experience of leading local/regional or global teams- Minimum 2-3 years' clinical trial project management experience- 7 years' work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company- Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)- Must be a local/country expert with identifiable project management experience locally- Build strong site relationships as well as other local relationships to ensure end to end study delivery is met.
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.
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