Senior Manager, GDO CSAR (Interactive Response Technologies)

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.

Senior Manager, GDO CSAR (Interactive Response Technologies)

Live

What you will do

Let's do this. Let's change the world. In this vital role you will serve as Technical Team Leader and primary point-of-contact to ensure delivery of global IRT services, including overall operational accountability for delivery of Interactive Voice/Web Recognition Systems ( IxRS) for Amgen clinical trials. The Senior Manager will lead a team of IRT Technical Specialists responsible for the design, implementation, and maintenance of IxRS solutions for Amgen's clinical trials globally. The role will partner closely with Global Clinical Program Management, Biostatistics, Data Management, Site Management, Supply Chain, and other departments to ensure the delivery of key IxRS processes including enrollment/randomization and drug supply.

• The position is expected to partner effectively with other CSAR System leads and study teams to seamlessly ensure high quality deliverables and pursue opportunities, which broaden the use and integration of IRT technologies and services into Amgen's clinical development technologies, systems, and business processes. The position will serve to advance clinical programs by designing IRT systems which are fit-for-purpose, align to protocol requirements, and support new capabilities for innovative study types (e.g. Master Protocol, Adaptive Design, etc...).
• A proven technical track record and experience in leading a technical team of staff members and in providing administrative and career development oversight for staff.
• The candidate must be able to represent Amgen's business requirements and needs by effectively partnering and working with outsourced service delivery partners (FSP) while having strong communication skills to maintain a high level of transparency between clinical study team members, clinical drug supply, Clinical Data Management business units, and other stakeholders.
• Technical oversight of the development, implementation, and maintenance of IxRS functionality to ensure that study specific IRT solutions adhere to study protocols, Amgen policies, procedures, and standards, and is managed in a regulatory compliant manner.
• Responsible for leading the strategy of testing and quality delivery of IRT systems in order to ensure commitment to preserving patient safety. Through active service management of IRT service providers, the Senior Manager is responsible for representing Amgen within a key leadership position, and thus will co-chair Operational Management Team and Functional Management Team governance bodies in partnership with Amgen Global Supplier Services to ensure quality and timely service delivery alongside monitoring supplier performance across IxRS vendors.
• Accountable for all aspects of IVRS systems lifecycle including requirement gathering, user acceptance testing, system change management, and system retirement to advance clinical trial development.
• Strong attention to detail and timeline management by providing robust oversight to all IVRS system activities within SSU to meet site initiation and enrollment milestones.
• Influence IVRS/IWRS design and requirement decisions by being an active voice during early study start up discussions.
• Promote innovation, by acting as a strong advocate for automation and the advancement of new technologies to streamline IVRS.
• Leverage deep understanding of business processes to search for new methodologies which will drive efficiency, quality, and compliance.
• Act as a subject matter expert, be a single point of contact and escalation source for IVRS/IWRS challenges and risks.
• Respond promptly to internal or external quality audits/compliance inquires through a deep understanding of regulatory requirements.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go-getter with these qualifications.

Basic Qualifications

Doctorate degree & 2 years of clinical experience OR
Master's degree & 6 years of clinical experience OR

Bachelor's degree & 8 years of clinical experience and

Previous line management experience

Preferred Qualifications

• Master's degree in data science, computer science, business administration or related discipline
• 5+ years work experience in life sciences or a medical related field.
• Seasoned knowledge and deep experience in the use of IVRS/IWRS system technology and techniques in varying trial dosing/randomization designs.
• Strong leadership skills demonstrating the ability to champion new ideas and challenge the conventional mindset and status quo in order to bring to life improved methods of IXRS services and models in order to deliver unparalleled operational excellence within enrollment/randomization, drug assignments, and drug supply designs.
• Exemplary customer service skills, as demonstrated in being able to pivot quickly to emerging or changing business requirements while leveraging business relationships to efficiently deliver system solutions.
• Understanding of the IVRS/IWRS technical landscape including mobile app technology and vendor platforms.

Thrive

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.

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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 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.