Amgen Jobs

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

What you will do

Let’s do this. Let’s change the world. In this vital role you will interact with healthcare decision makers to communicate and advance the scientific platform as aligned with Amgen’s company goals and objectives

Clinical Trial Oversight Manager

• Represents local functional management team within Global Study Operations Site Management (GSO-SM)

• Maintains an effective collaboration with all partners and assures overall quality of work performed by site management staff supplied by our Functional Service Provider (eg Clinical Research Associates or CRAs, Clinical Trial Assistants or CTAs) in support of Amgen sponsored clinical trials in Spanish-speaking Countries' Cluster in Latin America Hub.

• Manage Sr. Associates Contracts & Budgets (SCBA) team & support them completing contracts/payments for Amgen sponsored and investigator sponsored clinical trials.

Responsibilities

• Primary point of contact for Functional Service Provider / vendor(s) for resource and capacity management, portfolio planning and prioritization, performance management including the identification, partner concern and resolution of quality and delivery issues

• Provides support of clinical study execution

• Provides Global Study Operations Site Management (GSO-SM) functional area expertise and actively collaborates in a dynamic cross-functional environment.

• Oversight of the site contracting budgeting and payment process

• Manager of Sr. Associates Contract & Budgets (SCBA) in Spanish-speaking Countries' Cluster in LATAM Hub

Key activities:

Performs sponsor oversight activities of Functional Service Provider, including staff performance (KPIs, report(s) metric analysis/review), to ensure quality and delivery of Amgen.

Clinical trials.

• Collaborates closely with Functional Service Provider Line Manager (FSP-LM) to ensure appropriate level of their staff oversight is deployed.

• Supports Functional Service Provider staff onboarding and training.

• Supervises staff involved in local site contracting and budget management, insurance, and payment process.

• Leads Sr. Associate Contracts & Budgets (SCBA) onboarding and training.

• Point of escalation for all partners to support resolution of issues eg quality, staff turnover and performance concerns

• Works with Functional Service Provider(s) to ensure timely and appropriate planning, resource and capacity management from study start up to close-out.

• Conducts on-site quality visits with Clinical Research Associates where/when appropriate and supports the maintenance of Amgen investigator site relationships.

• Supports inspection readiness, local country and site level audits and regulatory inspections when applicable including CAPA resolution.

• Coordinates and is responsible for the Functional Management Team (FMT) Meetings and any other country-level project review meetings, if applicable.

• Involved in local and global site management and cross-functional partner partnership.

• Actively participates in role forums including local and global functional and cross-functional initiatives.

Basic Qualifications

• Doctorate degree OR

• Master’s degree OR

• BA/BS/BSc or qualified nurse (RN)

• Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience (clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)

Preferred Qualifications:

• Broad work experience working in life sciences or medically related field, including clinical site management experience, obtained working on clinical trials in a biotech, pharmaceutical or Contract Research Organization (CRO) company.

• Experience as a Clinical Research Associate, Clinical Trial Assistant, and/or Clinical/Regional Manager in the biopharmaceutical industry

• Experience in a project leadership role

• Experience working with or for Functional Service Provider (FSP) or Contract Research Organizations (CRO)

• Supervisory Experience

• Knowledge of or work experience with a biopharmaceutical Global R&D Compliance and Audit (GRDCA) or Quality Assurance department

Knowledge

• Familiarity with sophisticated concepts of clinical research

• Extensive knowledge of Good Clinical Practices, Clinical Trial regulations and guidelines

• Proven understanding of clinical trial operations

• Understanding of Functional Service Provider operational model

• Computer and system operation skills (Excel)

• Relevant therapeutic area education and training

• Detailed understanding of customer service

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization.

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a 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 an accommodation.

Join Us

If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney diseases, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.