Clinical Systems & Analytical Reporting Manager

Career Category

Job Description

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.

Clinical Systems & Analytical Reporting Manager

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for assisting with technology implementation and study deliverables tasks. The successful candidate will have a background in clinical application technologies and be a strong leader with demonstrated ability to influence stakeholders, to engage cross-departmentally, and to partner with the vendor to ensure delivery of services. The candidate should be technologist with a desire to learn and adapt to a changing technology ecosystem.

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

• Provide technical and business process input / expertise on new and emerging technologies/vendors for clinical trial execution.
• Serve as the technical liaison with study teams to gather/review business requirements.
• Assist with the implementation of new features and keep up to date on application releases.
• Assist with the evaluation of configuration settings and permissions for the application.
• Develop integration specifications between applications
• Deliver study specific tasks for study milestones (as needed).
• Facilitate rapid issue resolution and keep stakeholders informed.
• Partner with the vendor for the development of customized scripts, reports, datasets, or other solutions to support critical business processes.
• Build effective relationships and partnerships within Global Development Operations (GDO), IS, Global Statistical Programming, Global Safety, Compliance, Quality Assurance, Functional Service Provider (FSP) and EDC vendors.
• Lead or contribute to system related or process improvement initiatives at the departmental, cross-departmental, or wider Programming, Analytics & Solutions organization.
• Ensure documentation is consistent with established processes and SOPs.
• Assist in preparing for and responding to audit findings (internal or external).
• Delegate tasks to assigned staff, FSP, or contractors that support larger deliverables and projects.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications:

Basic Qualifications:

Doctorate Degree

Or

Master's Degree and 3 years of clinical experience

Or

Bachelor's Degree and 5 years of clinical experience

Or

Associates degree and 10 years of clinical experience

Or

High school diploma/GED & 12 years of clinical experience

Preferred Qualifications:

• BA, BS, RN degree in the life sciences, computer science, business administration or related discipline
• 5 years of experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical product development (clinical research or clinical operations experience obtained at a biotech, pharmaceutical or CRO company)
• Strong understanding of the concepts of clinical research and drug development
• Experience with one or more clinical trial technologies (e.g., EDC, CTMS, eTMF, site facing technologies, RTSM/IVR, ePRO, eCOA) along with integration design practices
• Knowledge of platform configuration settings
• Experience leading technical projects
• Must be able to work in a global team-based matrix environment (multi time zones)

Skills

• Strong project management skills with commitment to timeline management.
• Strong problem solving and decision-making abilities
• Negotiation skills to influence decision-making
• Detail oriented
• Working knowledge of programming languages (e.g., SQL, SAS)

Supplemental Experience:

• Bro