Career CategoryClinical
Job DescriptionSr Mgr Local Study Operations What you will do Let's do this. Let's change the world. In this role, you will lead the skill development of Local Study Operations Managers (LSOM), ensuring effective trial implementation within the country and strong alignment with global strategies. You will oversee the delivery of the country's study portfolio-managing scope, timelines, and budgets-through the leadership of LSOM. Working in close partnership with the Country GSSO Head, you will help foster, enhance, and sustain an optimal clinical research environment that supports global R&D objectives. Additionally, you will drive alignment and continuous improvement in LSOM execution by integrating best practices, promoting digital innovation, and facilitating robust knowledge sharing across the team.
IMPORTANT PLEASE READ! PLEASE SUBMIT YOUR CV IN ENGLISHKey accountabilities- Ensure the successful delivery of the study portfolio assigned to LSOMs.
- Oversee LSOMs' fulfillment of responsibilities throughout the assigned country portfolio, from feasibility through to study close-out.
- Monitor portfolio progress, provide risk and quality oversight, and support issue escalation and resolution for LSOMs.
- Manage LSOM and LSOM vendor performance to guarantee high-quality study execution, serving as the primary escalation point for local study challenges, driving solutions, and ensuring portfolio targets are met within the country.
- Mentor, train, and support the professional development of LSOMs to prepare them for managing complex trials.
- Build and maintain a high-performing team.
- Facilitate close collaboration between the study strategy team and local study teams to effectively manage the assigned portfolio.
- Promote cross-functional collaboration among country teams to ensure successful delivery of the country portfolio.
- Support discussions regarding study placement decisions based on country capabilities and growth potential.
- Proactively evaluate risks, quality trends, and resource requirements; implement mitigation strategies and drive continuous improvement in country operations.
- Lead initiatives to enhance operational efficiency and encourage sharing of best practices.
- Manage resource allocation and workload distribution across LSOMs, including both FSP and FTE personnel, to optimize trial execution and align with global priorities.
- Ensure adherence to regulatory and quality standards where applicable.
- Collaborate with and support the country head in engaging cross-functional stakeholders, aligning on trial deliverables, and managing escalations.
What we expect of you We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an individual with the following qualifications.
Basic Qualifications: - Doctorate degree & 2 years of clinical execution experience OR
- Master's degree & 6 years of clinical execution experience OR
- Bachelor's degree & 8 years of clinical execution experience OR
- Associate's degree & 10 years of clinical execution experience OR
- High school diploma / GED & 12 years of clinical execution experience
- In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above
- Advanced English proficiency
Preferred Qualifications: - 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 managing multiple teams / direct reports across multiple clinical functions / trials
- Experience at, or oversight of, clinical research vendors (CRO's, central labs, imaging vendors, etc.)
- Experience managing clinical operations across relevant geography / region, including strong understanding of local regulatory requirements around global clinical trials
What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
Amgen is proud to have been recognized as one of LinkedIn Top 25 Companies in Canada for career growth. Click HERE for more details.
The salary for this position is $150,773 - $203,987 CAD.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.
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Apply now and make a lasting impact with the Amgen team.careers.amgen.com 
