The Manager, CSAR - Electronic Data Interchange and Acquisition

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 you

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

Knowledge

Preferred Qualifications

Basic Qualifications

Skills Required

Systems Development Life Cycle, Data Management, drug development, Clinical Trials, Risk Analysis, Quality Management