Amgen

Study Start-up Manager

Amgen

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $122,229 - $150,449 per year

Tech Stack

About the role

  • Drive the planning and execution of clinical study start-up activities
  • Ensure 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
  • Own and manage study start-up plans and milestones
  • Act as the primary point of contact for cross-functional start-up teams
  • Identify, assess, and mitigate risks proactively
  • Partner closely with Study Delivery Leads, managers, and local teams
  • Apply strong operational and regulatory knowledge to enable high-quality execution
  • Manage internal resources and external suppliers
  • Contribute to continuous improvement by sharing expertise, mentoring colleagues, and developing best practices

Requirements

  • Pharma and clinical trial processes and operations expertise
  • Experience leading and managing global teams
  • Project management experience
  • 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
  • Experience directly managing people or leading teams, projects, programs, or directing the allocation of resources
  • Preferred: 5 years work experience in life sciences or medically related field, including 3 years of biopharmaceutical clinical research experience
  • 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
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
  • Flexible spending accounts
  • A discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical study start-upclinical trial processesproject managementrisk-based monitoring modelsclinical site managementclinical execution
Soft Skills
leadershipcommunicationmentoringcollaborationproblem-solving
Certifications
PMP Certification