Clinical Systems and Analytical Reporting (CSAR) Study Design and Programming Sr. Manager

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.

Let’s do this. Let’s change the world. In this vital role you will report to the Sr. Director/Director, Clinical System and Analytical reporting and will serve as the lead over the Study Design and Programming. They will plan and oversee implementation of Clinical Systems and Analytical Reporting (CSAR) key operations/activities, participate in determining and setting vision and strategy and direction for the Study Design and Programming operations, and lead departmental or cross functional initiatives or projects.

The position is expected to partner effectively with other CSAR Operations globally and cross functional staff to seamlessly ensure high quality deliverables with functional service providers, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables of both internal and/or oversight of external vendors or partners. The CSAR Sr. Manager will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, collaborator engagement, and change management.

The successful candidate will be a strong leader with demonstrated ability to influence collaborators, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of overseeing and effective partnership with external vendors or service delivery partners in delivering systems support or study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC)

Roles & Responsibilities :

• Provide line management and coaching staff to develop and grow their careers
• Oversee functional technical capability or service which may include oversight of internal and/or externalized resources (CW/vendor services)
• Manage, monitor and report on progress of Clinical system projects
• A leader for specific CSAR core competency areas in partnership with Functional Service Provider or external services; e.g. study database design and build
• Contribute to development of outsourcing strategies and long-term relationships with insourcing/outsourcing partners
• Lead or contribute to develop and implement strategic direction of CSAR and the wider GDO organization
• Lead or contribute to key or interdepartmental initiatives / projects with particular focus in system or process improvements
• Ensure efficient and consistent use of EDC system and ensure the use is aligned with the established procedures or standards
• Identify, recommend or implement system enhancements, new tools or emerging technologies to decrease database development cycle times and foster a collaborative working environment
• Ensure documentation supports CSAR operational or technical activities is in a complete manner and consistent with regulatory and the established processes
• Develop, review and implement policies, SOPs and associated documents
• Assist in preparing for and responding to audit findings (internal or external)
• Act as SME and provide coaching and mentoring to internal staff or providers

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

• Doctorate degree and 2 years of computer science, business administration ,life science or a medically related field or related discipline experience OR
• Master’s degree and 8 to 10 computer science, business administration ,life science or a medically related field or related discipline experience OR
• Bachelor’s degree and 10 to 14 computer science, business administration, life science or a medically related field or related discipline experience OR
• Diploma and 14 to 18 years of computer science, business administration, life science or a medically related field or related discipline experience
• General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
• Previous line management experience

Preferred Qualifications:

• Extensive work experience in data management in the Pharmaceutical or Biotech Industry
• General experience in a global organization
• Previous experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc)

• Good Clinical Practice
• Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking
• Clinical Systems landscape and/or Analytical platforms/reporting technology including RAVE & Veeva platforms
• Understanding of managing and providing oversight of operations with FSP/MSP or other vendor service provider model.
• Drug development and clinical trials processes
• Clinical trial databases and applications
• Systems development lifecycle
• Project planning and management
• Collaborating and leading global cross-functional teams (team/matrix environment)
• Quality management and Risk Analysis
• Regulatory filings and inspections
• Process improvement methodologies
• Management of external suppliers
• Setting goals and training plans to enhance talent management/career development of staff

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.

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.