Sr Mgr Local Study Operations

Biopharma Careers; Mississauga; On-site; CAD 151,000 - 204,000; Full time

Job summary

Amgen is seeking a Sr Mgr Local Study Operations to lead the development and performance of Local Study Operations Managers across the country. You will align with global strategies, drive trial delivery within scope, timelines, and budgets, and partner with the Country GSSO Head to sustain an optimal clinical research environment.

You will mentor LSOMs, promote best practices, oversee vendor performance, and enable cross-functional collaboration to meet country portfolio targets and ensure

Qualifications

• Doctorate with 2+ years of clinical execution experience.
• Master's with 6+ years of clinical execution experience.
• Bachelor's with 8+ years of clinical execution experience.
• Associate's with 10+ years of clinical execution experience.
• High school diploma with 12+ years of clinical execution experience.
• 7 years life sciences experience including 4 years in clinical research.
• Experience managing multiple teams across clinical functions and trials.
• Experience overseeing clinical research vendors (CROs, labs, imaging).
• Experience leading clinical operations across geography with regulatory knowledge.

Responsibilities

• Lead LSOM development and country trial delivery, aligning with global strategies.
• Oversee LSOMs from feasibility through study close-out with quality oversight.
• Monitor portfolio progress, risk, and issue escalation; drive solutions.
• Manage LSOM performance and LSOM vendor relationships for high-quality execution.
• Mentor, train, and develop LSOMs to handle complex trials.
• Foster cross-functional collaboration to meet country portfolio targets.

Skills

Leadership

Cross-functional collaboration

Strategic planning

Mentoring

Education

Doctorate with 2 years of clinical execution experience

Master's with 6 years of clinical execution experience

Bachelor's with 8 years of clinical execution experience

Associate's with 10 years of clinical execution experience

High school diploma / GED with 12 years of clinical execution experience

Job description

Sr Mgr Local Study Operations

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission, to serve patients living with serious illnesses, drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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.

Key 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

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.

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.

privileges of employment. Please contact us to request accommodation.

Equal Opportunity

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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.

careers.amgen.com