Site Engagement Senior Manager (US Remote)

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Site Engagement Senior Manager (US Remote)

Live

What you will do

Lets do this. Lets change the world. In this vital role you will develop, implement and maintain an integrated site engagement and operational role at key/targeted sites in line with Global Development pipeline to support strategic global study strategy plan to accelerate development of marketed products and early pipeline assets. You will also maintain an effective collaborative partnership with all partners, ensuring aligned and harmonious approach to sites experience with Amgen interactions.

Responsibilities

Leadership of Operational Site Engagement

• Align and lead identification and strategic partnership with key sites to implement a collaborative initiative for clinical trial execution.
• Accountable for strategic long-term operational partnerships with key sites, provide local intelligence, and contribute to maintaining a consistent and coherent voice as part of Amgens overarching engagement strategy. Collaborate with other cross functional roles for tailored global execution of study(ies).
• Proactive and accountable to drive expansion of Amgens strategic relationships and meet clinical operational needs as subject matter expert.
• Primary site-facing, cross-study, operational decision-maker between Amgen and designated key sites for the purposes of establishing Amgen-Institutional operational working practices.
• Maintain country expertise, site knowledge to navigate with Amgen and sites with targeted and tailored communication.
• Develop, drive and monitor site operational strategies and performance across all therapeutic areas and studies, in strong collaboration with Amgen partners
• Assimilate and report external feedback to evaluate and propose operational process efficiencies, focus and direction for site collaboration on clinical trials
• Orchestrate relationship management and strong internal alignment with Amgen partners (medical, study management, site management, and other key -stakeholders) to drive operational efficiencies
• Strong collaboration with regional and/or country Study Lead (RCTM/LCTM*) to ensure clear roles and responsibilities. Communicate cross-study lessons learned, and maintain consistent working relationships with sites
• Share information and cross-study metrics to Key Stakeholders, e.g. DOM, DFM, CTOM, Study Managers etc.

Locally accountable for key, targeted sites execution of clinical studies

• Build and develop strong relationships with key sites to engage with Amgen as Choice for clinical trial participation, to effectively advance site operational engagement and better understand current site processes to enhance our clinical trial execution.
• Regular communication with key sites to connect on all trials/all stages to determine trends and opportunities and enhance sites experience with Amgen. On-site visits as appropriate (per site and situation)
• Maintaining quick and direct access to key sites leadership & operation teams, point of escalation for operational, cross-study potential barriers and operational issues
• Internal point of contact to navigate working with key sites, and to help key sites navigate working with Amgen
• Centralize and socialize site intelligence technology, such as working practices, operational documents, to enhance clinical trial efficiencies at site
• Participation in cross-functional task forces / process improvement groups

GSO quality management

• Actively participates in role forums including local and global functional and cross-functional initiatives
• Participates in Functional Management Team (FMT) Meetings as required and applicable country-level project review meetings

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Clinical professional we seek is a strong leader with these qualifications.

Basic Qualifications

• Doctorate degree and 2 years of work experience in life sciences or medically related field or
• Masters degree and 5 years of work experience in life sciences or medically related field or
• Bachelors degree and 7 years of work experience in life sciences or medically related field

Preferred Qualifications

• 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)
• Country clinical operations experience and/or regional study management experience
• Expertise and in-depth understanding of site engagement with clinical trials, or building and/or coordinating community research networks

Knowledge

• In depth understanding of drug development process, clinical trial conduct, ICH-GCP and local regulations, requirements, and guidelines
• Project and Program management including oversight of quality, study deliverables, budgets and timelines
• Various therapeutic area knowledge
• Fluency in written and spoken English
• Clinical trial management systems and reporting tools
• Utilization of Key Performance Indicators (KPIs)

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also 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.

careers.amgen.com
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 disease, 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.

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, or disability status.

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.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.