Manager, CSAR - Study Design and Programming

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.

Manager, CSAR - Study Design and Programming

What you will do

Let’s do this. Let’s change the world. We are looking for a dedicated individual to join us as a Study Designer and Edit Check Programmer, reporting directly to the Sr. Manager, Clinical Systems and Analytical Reporting.

The successful candidate will play a crucial role in adhering to Amgen standards, procedures, and best practices to build and program studies in our clinical trial database. This position will require effective partnership with other CSAR Operations and cross-functional staff to ensure seamless, high-quality deliverables and activities related to the use of electronic data capture technology.

We are seeking a strong leader who can confidently influence collaborators and contribute individually to study-specific and general CSAR/GDO projects or operational work. The ideal candidate will have proven experience in partnering effectively with cross-functional teams to deliver systems support and study deliverables. Additionally, they should have operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC).

Responsibilities include, but are not limited to, the following:

• Support of clinical trial platform technologies
• Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight.
• Coordinating and providing programming support to Clinical Study Teams
• Ensure efficient and consistent use of EDC system and ensure the use is aligned with the established procedures or standards.
• Acting as a technical point of contact for systems deliverables on defined programs
• Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment.
• Providing technical and business process input / expertise on new and emerging technologies
• Develop, review and implement policies, SOPs and associated documents
• Ensure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes.
• Assist in preparing for and responding to audit findings (internal or external).

Knowledge

• Good Clinical Practice
• Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking
• Drug development and clinical trials processes
• Data management processes
• Clinical trial databases and applications
• Study build and Edit check development
• Programming Languages
• Systems development lifecycle
• Project planning and management
• Collaborating with global cross-functional teams (team/matrix environment)
• Quality management and Risk Analysis
• Regulatory filings and inspections
• Process improvement methodologies

Preferred Qualifications

• Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related field
• Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena
• General project management and planning experience
• Experience in oversight of outside vendors (CRO’s, central labs, imaging vendors, IRT vendors, etc.)

Basic Qualifications

• Bachelors degree or equivalent in life science, computer science, business administration or related field
• Specialist knowledge / experience in life sciences or a medically related field
• General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)

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.

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

Apply now and make a lasting impact with the Amgen team.

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.