Job Description

Career Category ResearchJoin Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionxe2x80x94to serve patients living with serious illnessesxe2x80x94drives all that we do.Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.The Manager, CSAR - Electronic Data Interchange and AcquisitionWhat you will doLets do this. Lets change the world.The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Electronic Data Interchange/Acquisition programming activities. The Manager, CSAR - Electronic Data Interchange and Acquisition will develop the Data Acquisition Requirements Specification (DARS) document to outline metadata transfer requirements, establish and validate vendor integration criteria, and manage the processing of electronic data from vendors.The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, 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 at the study and portfolio level. Manager, CSAR - Electronic Data Interchange and Acquisition will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and change management.The successful candidate will be a strong leader with demonstrated ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has 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
• Works collaboratively with Clinical Data Management to meet study deliverables and timelines
• Acting as a technical point of contact for systems deliverables on defined programs
• Experience in writing the Data Acquisition Requirements Specification (DARS) document to specify metadata transfer requirements, setting up and testing RWS integration requirements supporting study closure with final data loads and transfer discontinuation, configuring data upload gateways between external vendors and Amgen.
• Providing technical and business process input / expertise on new and emerging technologies
• Develop, review and implement policies, SOPs and associated documents
• Assist in preparing for and responding to audit findings (internal or external).

What we expect of youWe are all different, yet we all use our unique contributions to serve patients.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
• Programming of clinical trial databases and applications
• Experienced in collecting, maintaining, aggregating, and supporting data cleaning controls for external (non-EDC) data, importing clinical study data from various sources including central labs and imaging vendors.
• Systems development lifecycle
• Programming Languages
• 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 (CROs, central labs, imaging vendors, IRT vendors, etc.)

Basic Qualifications

• Bachelors degree or equivalent in life science, computer science, business administration or related field with6 to 8years of experience.
• Masters degree and 4 to 6 years of experience.
• 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 usAs 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, well 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.comAs 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..

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