Local Study Operations Manager (LSOM)

Amgen • Thousand Oaks, CA

1d

About The Position

You’ve 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 world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Local Study Operations Manager (LSOM) 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 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.

Requirements

• Doctorate degree or Master’s degree and 3 years of clinical trial project management experience or Bachelor’s degree and 5 years of clinical trial project management experience or Associate’s degree and 10 years of clinical trial project management experience or High school diploma / GED and 12 years of clinical trial project management experience

Nice To Haves

• 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.

Responsibilities

• 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

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees