Local Trial Manager (LTM)

Amgen Inc.

3.6

(9)

South Korea

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-176307

    Position summary

    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.
    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 local language 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.

    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

    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.

    Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging