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)
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 coordinate 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, and the achievement of clinical trial results within the local country.
Key Activities:
1. Partner with global and local country teams to develop high-level country strategy and actively drive study progress and local study delivery.
2. Plan, manage, and oversee the implementation of clinical studies in accordance with the global program strategy, through leadership and engagement of the cross-functional Local Study Team.
3. Communicate country status (including timelines and results) to key partners and update relevant systems for transparency.
4. Provide country-level input into the Country Operational Plan and collaborate with the Development Feasibility Manager and Global Clinical Managers to ensure local study delivery.
5. Support internal audits and inspections, contribute to CAPAs, and lead resolution of issues when appropriate, including vendor management.
6. Assign and support study staff, and continually review country-level risk mitigation to ensure study delivery.
What we expect of you
We are all different, yet we all use our contributions to serve patients. The qualified professional we seek is a Trial Manager with these qualifications:
* Doctorate degree OR
* Master’s degree & 3 years of related experience OR
* Bachelor’s degree & 5 years of related experience OR
* Associate’s degree & 10 years of related experience OR
* High school diploma / GED & 12 years of related experience
Additional qualifications include advanced knowledge of global clinical trial management, fluency in the local language and business English.
Preferred Requirements
* BA / BS / BSc
* Minimum 2-3 years’ experience leading local/regional or global teams
* Minimum 2-3 years’ clinical trial project management experience
* 7 years’ work experience in life sciences or related field, including 4 years in clinical research
* Experience managing external vendors (e.g., CROs, labs, imaging vendors)
* Local project management expertise and strong site relationships
Some of the rewards of working here
We support your professional and personal growth through career development resources, a diverse and inclusive community, and a comprehensive Total Rewards Plan including health, finance, work/life balance, and career benefits. Our benefits are rated above 4 stars on Glassdoor.
Apply now for a career that defies imagination at careers.amgen.com.
Amgen is an Equal Opportunity employer and provides reasonable accommodations for individuals with disabilities throughout the application and employment process.
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