Informed Consent Manager

Amgen • Thousand Oaks, CA

17h

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Study Start Up Hub - Informed Consent Manager What you will do Let’s do this. Let’s change the world. In this vital role you will help bring innovative medicines to patients by delivering high-quality, patient-centric informed consent forms that support the successful execution of global clinical studies 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. 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 working within a global team structure and project management experience Tech Skills: No prior Veeva experience required 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 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 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. 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 $129,233-159,079. 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 for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range

Requirements

• Pharma Expertise: Requires pharma and clinical trial processes and operations expertise; no relevant therapeutic knowledge required
• Management Experience: Requires experience working within a global team structure and project management experience
• Tech Skills: No prior Veeva experience required
• 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

Nice To Haves

• 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.

Responsibilities

• 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.

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, 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED