Full-Time

Senior Manager Local Study Operations

Updated on 9/9/2026

Amgen

Amgen

10,001+ employees

Biotech company creating biologic medicines

Compensation Overview

CA$150.8k - CA$204k/yr

Remote in Canada + 1 more

More locations: Mississauga, ON, Canada

Remote

Bachelor's, Master's, PhD, Associate's

Category
Biology & Biotech (1)
Required Skills
Risk Management

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Requirements
  • A doctorate degree and 2 years of clinical execution experience, or a master's degree and 6 years of clinical execution experience, or a bachelor's degree and 8 years of clinical execution experience, or an associate's degree and 10 years of clinical execution experience, or a high school diploma/GED and 12 years of clinical execution experience.
  • At least 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation; this experience may run concurrently with the required technical experience.
  • Advanced English proficiency.
Responsibilities
  • Lead the skill development of Local Study Operations Managers and ensure effective trial implementation within the country aligned with global strategies.
  • Oversee delivery of the country's study portfolio through the leadership of Local Study Operations Managers, managing scope, timelines, and budgets.
  • Ensure successful delivery of the study portfolio assigned to Local Study Operations Managers.
  • Oversee Local Study Operations Managers' responsibilities throughout the country portfolio, from feasibility through study close-out.
  • Monitor portfolio progress, provide risk and quality oversight, and support issue escalation and resolution.
  • Manage Local Study Operations Manager and vendor performance, serve as the primary escalation point for local study challenges, drive solutions, and ensure portfolio targets are met.
  • Mentor, train, and support Local Study Operations Managers' professional development.
  • Build and maintain a high-performing team.
  • Facilitate collaboration between the study strategy team and local study teams to manage the assigned portfolio.
  • Promote cross-functional collaboration among country teams to ensure successful portfolio delivery.
  • Support study placement decisions based on country capabilities and growth potential.
  • Evaluate risks, quality trends, and resource requirements; implement mitigation strategies and drive continuous improvement.
  • Lead initiatives to improve operational efficiency and share best practices.
  • Manage resource allocation and workload distribution across Local Study Operations Managers, including FSP and FTE personnel, to optimize trial execution and align with global priorities.
  • Ensure adherence to applicable regulatory and quality standards.
  • Collaborate with and support the country head in engaging cross-functional stakeholders, aligning on trial deliverables, and managing escalations.
Desired Qualifications
  • Seven years of work experience in a life sciences or medically related field, including four years of biopharmaceutical clinical research experience on clinical trials in a biotechnology, pharmaceutical, or contract research organization company.
  • Experience managing multiple teams or direct reports across multiple clinical functions or trials.
  • Experience overseeing clinical research vendors, including contract research organizations, central laboratories, and imaging vendors.
  • Experience managing clinical operations across the relevant geography or region, including a strong understanding of local regulatory requirements for global clinical trials.

Amgen develops medicines that treat serious illnesses by using biologic therapies made from living cells. These therapies are designed to target specific disease processes, such as cancer, cardiovascular disease, and autoimmune conditions, and are produced through biotechnology methods that create proteins or antibodies. Amgen’s products are sold to patients and healthcare providers worldwide, with revenue funding ongoing research and development to discover new treatments. The company stands out by focusing on biologic medicines at a large scale and maintaining a steady pipeline of potential therapies across multiple disease areas, supported by global manufacturing and a commitment to bringing therapies to patients. Its goal is to improve patient outcomes by discovering and delivering new, effective treatments while reinvesting a significant portion of earnings into research and development.

Company Size

10,001+

Company Stage

IPO

Headquarters

Thousand Oaks, California

Founded

1980

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Simplify's Take

What believers are saying

  • Q2 2026 revenue reached $10.1 billion, and guidance rose to $38.2-$39.4 billion.
  • Repatha sales jumped 37% to $953 million, with Uplizna up 90%.
  • A federal judge blocked Colorado's Enbrel cap, preserving U.S. pricing flexibility.

What critics are saying

  • FDA proposed withdrawing Tavneos on April 27, 2026, after data manipulation findings.
  • Novartis pelacarsen failed Phase 3 in 2026, raising Amgen's olpasiran outcomes bar.
  • Colorado's Enbrel price-cap fight continues on appeal, threatening legacy cash flow through 2027.

What makes Amgen unique

  • Repatha, Evenity, Uplizna, and Tezspire diversify growth beyond Enbrel and Prolia.
  • Amgen's 7,297-patient OCEAN(a)-Outcomes gives olpasiran a large cardiovascular readout.
  • Hyderabad's Genome Valley center expands Amgen's R&D footprint with data-driven discovery.

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Benefits

Professional Development Budget

Conference Attendance Budget

Company News

Yahoo Finance
Sep 7th, 2026
Amgen's $437 olpasiran bet faces higher bar after Novartis Lp(a) drug fails Phase 3 trial

Amgen faces heightened scrutiny for its experimental heart drug olpasiran after rival Novartis's pelacarsen failed to reduce major cardiovascular events in a Phase 3 trial, despite successfully lowering lipoprotein(a) levels. The setback demonstrates that improving laboratory biomarkers may not translate to better patient outcomes. Amgen's OCEAN(a) outcomes study has enrolled 7,297 participants and is tracking heart-related deaths and procedures over roughly five years. While olpasiran uses a different design and may target different patients, pelacarsen's failure removes assumptions about the commercial value of lowering Lp(a). Amgen's shares traded at $437.23, sitting 19.54% above its estimated fair value of $365.76. The company reported $10.1 billion in second-quarter revenue and $3.5 billion in free cash flow.

Yahoo Finance
Sep 1st, 2026
Amgen's Repatha hits $953M in Q2 sales, up 37% as Cramer calls it "biggest market of all time

Jim Cramer highlighted Amgen's cholesterol drug Repatha as a key driver behind the company's 31% year-to-date rally, calling it an overlooked catalyst by Wall Street. The injectable treatment, administered every two weeks, reduces death risk by 20% in patients at high risk for heart attack or stroke. Repatha generated $953 million in second-quarter sales, up 37% year-over-year. US new prescriptions surged over 50%, split evenly between cardiologist use and primary-care adoption for high-risk patients. Cramer noted the drug works against diabetes and high cholesterol, though insurance reimbursement has posed challenges. Amgen trades at a forward PE of 19, compared to Eli Lilly's 32, whilst outperforming Lilly's 10% gain this year. Repatha is one of six growth drivers representing nearly 70% of Amgen's product sales. The company raised full-year revenue guidance to $38.2-$39.4 billion.

Yahoo Finance
Aug 19th, 2026
Amgen surges 3.5% to $440 as healthcare stocks hit record high on strong Q2 results

Amgen shares jumped 3.5% to $440.08 on Wednesday as healthcare stocks reached record highs. The biotech company reported second-quarter revenue of $10.1 billion, up 10%, whilst GAAP earnings surged 65% to $4.37 per share. Twenty-two of Amgen's medicines posted double-digit sales growth, with seventeen products generating over $1 billion in annualised sales. Six key growth products climbed 26% and now account for nearly 70% of product revenue. The rally came as investors rotated into healthcare following excitement around Merck and Moderna's melanoma breakthrough. However, Amgen now trades at a 19% premium to its fair value estimate of $365.04, putting pressure on execution as some products like Prolia face headwinds.

Yahoo Finance
Aug 14th, 2026
Amgen and Regeneron emerge as GLP-1 investment alternatives beyond Eli Lilly and Novo Nordisk

Amgen and Regeneron could benefit from surging demand for GLP-1 drugs, which traditionally treated diabetes but now address obesity and obstructive sleep apnea. Amgen's stock is up 27% this year, with second-quarter revenue rising 10% year-over-year to $10.1 billion. The company is testing MariTide, an investigational GLP-1 medicine, in phase 3 studies for weight management and diabetes. MariTide could be administered monthly or less frequently, offering a convenience advantage over current daily or weekly treatments. Regeneron is also positioned to capitalise on the GLP-1 market expansion. Both companies present alternatives to current market leaders Eli Lilly and Novo Nordisk for investors seeking exposure to the growing GLP-1 drug category.

PR Newswire
Aug 12th, 2026
Amgen to open new science and innovation centre in Hyderabad's Genome Valley

Amgen announced plans to open a new Science and Innovation Center in Genome Valley, Hyderabad, expected to be operational in 2027. The facility will join Amgen's global Research and Development network of seven research laboratories, expanding the company's scientific capabilities. The center will bring together scientists and technologists across discovery chemistry, drug metabolism and pharmacokinetics, and precision medicine. It will integrate experimental science with data and digital innovation to accelerate the discovery and development of medicines. "The new center in Genome Valley expands the way we integrate experimental science with data and technology across our global research capabilities," said Jay Bradner, executive vice president of Research and Development, Artificial Intelligence and Data at Amgen. The facility will complement Amgen's existing technology and innovation site in Hyderabad.