Amgen Inc

Study Start-up Manager

Amgen Inc • $122K — $150K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Pharma and clinical trial operations expertise required; no therapeutic knowledge necessary.
  • Experience managing global teams and project management is essential.
  • No prior Veeva experience is necessary.
  • Education requirement: Doctorate, Master's with 3 years, Bachelor's with 5 years, Associate with 10 years, or High school diploma with 12 years in clinical execution.
  • Demonstrated leadership experience in managing teams or projects is required.

Responsibilities

  • Lead planning and execution of clinical study start-up activities globally and locally.
  • Manage study start-up plans and milestones, ensuring progress and issue resolution.
  • Serve as primary contact for cross-functional start-up teams, enhancing accountability and collaboration.
  • Proactively identify and mitigate risks, contributing to study risk assessments.
  • Collaborate closely with Study Delivery Leads and local teams for updates and solutions.
  • Apply operational and regulatory knowledge to ensure high-quality execution of studies.
  • Oversee internal resources and external suppliers for compliant start-up activity delivery.

Benefits

  • Comprehensive benefits package including medical, dental, and vision coverage.
  • Generous Retirement and Savings Plan contributions.
  • Discretionary annual bonus program and stock-based long-term incentives.
  • Award-winning time-off plans with bi-annual company-wide shutdowns.
  • Flexible work models, including potential for remote work arrangements.
Full Job Description
Career Category
Clinical
Job Description

Study Start Up Hub - Study Start-up Manager

What you will do

Let's do this. Let's change the world. In this vital role you will drive the planning and execution of clinical study start-up activities, ensuring trials are launched efficiently, compliantly, and to the highest quality standards.
  • Lead the planning and delivery of clinical study start-up activities from global to local, ensuring timelines, quality, budget, and regulatory compliance are met.
  • Own and manage study start-up plans and milestones, maintaining oversight of progress and resolving issues to keep delivery on track.
  • Act as the primary point of contact for cross-functional start-up teams, driving clarity of roles, accountability, and collaboration.
  • Identify, assess, and mitigate risks proactively, contributing to study risk assessments and ensuring timely study start.
  • Partner closely with Study Delivery Leads, managers, and local teams, providing clear updates, solutions, and escalation where needed.
  • Apply strong operational and regulatory knowledge (e.g. ICH-GCP, submissions and start-up processes) to enable high-quality execution.
  • Manage internal resources and external suppliers to ensure efficient and compliant delivery of start-up activities.
  • Contribute to continuous improvement by sharing expertise, mentoring colleagues, and developing best practices within the SSU hub.


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:
  • Pharma Expertise: Requires pharma and clinical trial processes and operations expertise; no relevant therapeutic knowledge required
  • Management Experience: Requires experience leading and managing global teams and project management experience
  • Tech Skills: No prior Veeva experience required
  • Doctorate degree OR
  • Master's degree and 3 years of clinical execution experience OR
  • Bachelor's degree and 5 years of clinical execution experience OR
  • Associate's degree and 10 years of clinical execution experience OR
  • High school diploma / GED and 12 years of clinical execution experience
  • In addition to meeting at least one of the above requirements, you must have 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


Preferred Qualifications:

  • 5 years work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
  • Experience working in global clinical trial teams across multiple geographies
  • Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management
  • PMP Certification


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.

The annual base salary range for this opportunity in the U.S. is $122,229-150,449.

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 that may include:
  • 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


Apply now

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About Amgen Inc

Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases. The company is values-based and deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious diseases. They offer products for treating illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.

Amgen Inc Careers

Join the dynamic team at Amgen Inc, a biotechnology pioneer dedicated to discovering, developing, and delivering innovative human therapeutics. At Amgen, we offer more than just job opportunities; we invite you to be part of a culture of leadership, diversity, and innovation.

Work You’ll Do

At Amgen Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that brings real solutions to patients worldwide. Our commitment to your career growth is evident in our professional development and leadership training programs designed to nurture your potential.

Innovate and Lead

Amgen Inc stands at the forefront of biotech innovation. Our team is constantly pushing the boundaries of science and technology. By joining us, you will contribute to a legacy of medical breakthroughs that improve the lives of millions.

Be Part of a Great Team

Amgen’s inclusive culture and commitment to diversity are integral to our success. We believe in empowering our employees with the skills and networking opportunities they need to thrive. Our team’s collaboration is the key to developing groundbreaking solutions.

Future-Proof Your Career

Amgen Inc offers a variety of career paths, from research and development to marketing and sales, providing near-limitless opportunities for advancement. Whether you are looking for a full-time position, an internship, or a leadership role, Amgen has a place for you. Our robust benefits package supports the well-being of our employees and their families, contributing to a fulfilling work-life balance.

Explore Job Opportunities

Discover the impact you can make with a career at Amgen Inc. We are hiring creative, curious, and motivated individuals ready to face challenges head-on. Explore our open positions that match your skills and interests.

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Join our team and stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. See what exciting and rewarding opportunities await.

Interview and Resume Tips

Prepare for your future with Amgen Inc by utilizing our resources designed to enhance your interview skills and polish your resume. Our hiring process is designed to identify and attract professionals who are driven to make a difference.

Amgen Inc—Where Careers Grow

At Amgen Inc, we are committed to turning innovative science into value for patients. If you are passionate about joining a team that makes a difference, search Amgen jobs today and take the first step towards a fulfilling career.

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Join us at Amgen Inc, where your career can flourish in an environment of innovation, leadership, and growth.
Learn more about Amgen Inc
Size
24,200 employees
Market Cap
$141.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7.2 billion
Founded
1980
5 Year Trend
+2.5%
Revenue
$25.4 billion
NASDAQ
AMGN
* Ladders Estimates

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