Informed Consent Manager
Amgen
full-time
Posted on:
Location Type: Remote
Location: United States
Visit company websiteExplore more
Salary
💰 $129,233 - $159,079 per year
About the role
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial experienceICF authoringquality checksversion controlstatus reportingprocess improvementregulatory compliancestudy protocol alignmentpatient feedback incorporationclinical research operations
Soft Skills
communicationcollaborationproblem-solvingattention to detailorganizational skillstime managementadaptabilityteamworkleadershipcritical thinking