Amgen

#WeareBiotech

Informed Consent Manager

ManagerManagerFull TimeRemoteTeam 10,001+Since 1980H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

21 days ago

Salary

$129.2K - $159.1K / year

High School10 yrs expExperience acceptedEnglish

Job Description

• Manage the end-to-end delivery of study-specific informed consent forms (ICFs), ensuring they are high quality, compliant, and delivered on time • Review, edit, and contribute directly to ICF content to ensure accurate alignment with study protocols and regulatory requirements • Work day-to-day with Study Delivery Teams and ICF Authors to develop ICFs that meet study timelines and operational needs • Perform quality checks on all study-level ICFs, resolving issues quickly to maintain speed and consistency • Partner with Patient Engagement teams to incorporate patient feedback and improve clarity, accessibility, and usability of ICFs • Coordinate ICF translations, version control, and country-specific updates to support global study execution • Maintain and actively manage study ICF tracking, reconciliation, and status reporting across studies • Identify and implement practical improvements to ICF processes, tools, and ways of working to improve delivery performance

Job Requirements

  • Doctorate degree OR Master’s degree & 2 years of clinical trial experience or equivalent OR Bachelor’s degree & 4 years of clinical trial experience or equivalent OR Associate’s degree & 8 years of clinical trial experience or equivalent OR High school diploma / GED & 10 years of clinical trial experience or equivalent
  • 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 clinical trial operations as a Clinical Research Associate
  • Experience in authoring ICF forms preferred
  • Experience in a clinical setting e.g. clinical site role may be an advantage.

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, 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

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