Manager, CSAR - Electronic Data Interchange and Acquisition Role Description The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical Reporting, focusing on Electronic Data Interchange/Acquisition programming activities. This role involves developing 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 requires cross-functional collaboration to ensure high-quality deliverables, support clinical systems, and oversee electronic data capture technologies. The Manager, CSAR will be responsible for study-level and portfolio-level quality and deliverables while also contributing to large system transformation projects with project management, subject matter expertise, partner engagement, and change management responsibilities. A strong leadership mindset and ability to influence partners is essential, along with individual contribution to study-specific and general CSAR/Global Development Operations projects. Responsibilities Support clinical trial platform technologies and ensure smooth operations. Enable data-driven decision-making by providing analytical insights. Coordinate and provide programming support to Clinical Study Teams. Collaborate with Clinical Data Management to meet study deliverables and timelines. Act as a technical point of contact for systems deliverables on defined programs. Develop the DARS document, specifying metadata transfer requirements. Set up and test RWS integration requirements, supporting study closure with final data loads and transfer discontinuation. Configure data upload gateways between external vendors and Amgen. Provide technical and business process 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). Basic Qualifications Bachelor's degree in Life Sciences, Computer Science, Business Administration, or related field with 9-13 years of experience. Proven experience in managing teams. Specialist knowledge/experience in Life Sciences or a medically related field. General biopharmaceutical clinical research experience (clinical trial experience at biotech, pharmaceutical, or CROs). Preferred Qualifications Advanced degree or equivalent in Life Science, Computer Science, Math, Statistics, Business Administration, or a related field with 9-13 years of experience. Broad knowledge/work experience in data management/programming in the pharmaceutical or biotech industry. Proven experience in managing teams. Project management and planning experience. Experience overseeing outside vendors (CROs, central labs, imaging vendors, IRT vendors, etc.). Must-Have Skills Good Clinical Practice. Expertise in performance management techniques, measures, problem-solving, and analytical thinking. Understanding of drug development and clinical trial processes. Data management processes. Clinical trial database programming and applications. Experience collecting, maintaining, and supporting data cleaning controls for external (non-EDC) data. Proficiency in importing clinical study data from central labs and imaging vendors. Knowledge of the systems development lifecycle. Programming languages expertise. Project planning and management. Ability to collaborate with global cross-functional teams (team/matrix environment). Quality management and risk analysis. Regulatory filings and inspections expertise. Process improvement methodologies. Soft Skills Excellent analytical and troubleshooting skills. Strong verbal and written communication skills. Ability to work effectively with global, virtual teams. High degree of initiative and self-motivation. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong presentation and public speaking skills.