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Local Trial Manager
hace 4 meses
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 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
Build strong site relationships as well as other local relationships to ensure end to end study delivery is met.
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 Local Trial Manager with these qualifications.
Minimum Requirements:
Doctorate degree
OR
Master’s degree & 3 years of Clinical Trials experience
OR
Bachelor’s degree & 5 years of Clinical Trials experience
OR
Associate’s degree & 10 years of Clinical Trials experience
OR
High school diploma / GED & 12 years of Clinical Trials experience
Preferred Requirements:
Educational Background Bachelor’s Degree in Life Science
Work experience in life sciences or medical related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
2 years leading local/regional or global teams experience
2 years Clinical Trial Project Management experience
Fluency in local language and business English
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
Thrive
What you can expect of us
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.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
