Job Description

Career Category ClinicalHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.Local Trial Manager (LTM)LiveWhat you will doLets do this. Lets 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

WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a Trial Manager with these qualifications.Basic Qualifications:Masters degree & 3 years of directly related experienceOrBachelors degree & 5 years of directly related experienceAdvanced knowledge of global clinical trial managementPreferred Qualifications:

• 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.

ThriveWhat you can expect of usAs 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.The salary range for this role in Canada is $124,000 - $143,000 CAD.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAmgen 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