Director, CSAR - System Study Services

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.

Director, CSAR - System Study Services

Let’s do this. Let’s change the world. In this vital role you will responsible for the successful execution of system deliverables and working with the global CSAR operational teams ensuring successful study delivery. The role will be accountable for clinical trial database build design, development and maintenance to ensure trial requirements are successfully achieved. To enhance consistency, adhere to industry and data collection standards, and increase proficiency the position will also work in strong collaboration with the Data Element Standards team to further define and build Global Library objects. These two fields will go hand-in-hand to serve clinical programs and drive acceleration during study start-up activities. Working with cross-functional teams, the position will drive forward standard methodologies within database design to meet the demands of new data types, act as a strong advocate for standardization, and develop new techniques to support data collection, cleaning, analysis and reporting.

The role will be influential and help set guidance as well as participate with the global CSAR teams to support oversight of electronic data acquisition activities, especially in nascent data types such as EHR, EMR, MHealth, advance imagery, eCOA, ePRO, and other emerging technologies or data sources/services.

Importantly, the leadership role will guide, coach, and mentor an internal Amgen staff and ensure performance of external FSP partners. The position will be expected to set prioritization, steward continuous improvement efforts which have direct system dependencies, and lead change management activities. The role will be accountable for supplier and vendor oversight ensuring quality, compliance, and performance standards are continuously achieved.

The following are key competencies for the Director CSAR - System Study Services position:

• Deploy technical solutions and systems that achieve clinical trial and program achievements.
• Accountable for the quality and timeliness in delivery of IRT, eCOA, CTDB and Non-CTDB outputs.
• Advance and maintain global library data standards strategy in partnership with GBDS DES.
• Operate under inspection-readiness and directly contribute to audits and regulatory requests.
• Influence study teams on the most effective approach to meet protocol requirements w/in study database build.
• Partner with cross-functional teams to operationalize new system features across the portfolio
• Results-driven providing progressive monitoring and tracking of vendor performance against SLAs
• Lead the team through impact assessments for database build migrations and change management tasks.
• Strong understanding of regulations which govern clinical system and clinical development practices.
• Act as a strong coach, providing constant feedback and mentoring to fellow staff members.
• Ability to lead organization change by influencing others across various functions and navigating the team through new processes and/or technical advances.
• Superior planning and communication skills; able to plan, set goals and define approach in highly ambiguous situations.
• Represent Amgen at industry forums presenting and influence industry movements related to the clinical development applications and systems.

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Master’s degree and 14 to 16 years of life science, computer science, business administration or related field OR
• Bachelor’s degree and 16 to 18 years of life science, computer science, business administration or related field
• Extensive work experience in life sciences under a focus in the management of clinical trial systems
• Familiar with system technologies of RAVE, IRT, mHealth devices (e.g. eCOA), other clinical technologies
• Previous line management experience, including management level staff

Preferred Qualifications:

• Extensive experience in technologies which support data collection, cleaning, data extraction within the Pharmaceutical or Biotech arena including RAVE, Veeva, clinical programming technologies
• Broad experience of working in a global organization
• Previous experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc)

• Recognized as a leader in data handling, collection methods, and standards in order to steer optimal use of study level systems and reports.
• Strong understanding of clinical trial processes and underlining system ecosystem.
• Superior knowledge of vendor oversight ensuring adherence to database cycle and quality measures.
• Understanding and practical use of system policies/guidelines (ISO, ICH ER/ES, GCP)
• Expertise in data structures, data models, and architecture to fuel downstream applications.
• End-to-End expertise of data flow from protocol to CSR
• Reporting and Systems development lifecycle
• Resource planning and management
• Working with global cross functional teams
• Quality management
• Regulatory filings and inspections
• Management of external suppliers
• Setting goals and training plans to enhance talent management/career development of staff

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.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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.