Job Title: Manager, CSAR – Electronic Data Interchange and Acquisition
Location: India – Hyderabad (On Site)
Job ID: R-210901
Date Posted: April 4, 2025
Category: Research
Job Summary
Amgen is seeking a Manager, CSAR – Electronic Data Interchange and Acquisition to lead data integration and vendor data management in support of clinical trials. This role includes authoring the Data Acquisition Requirements Specification (DARS), managing metadata transfer, configuring integration between external vendors and Amgen systems, and ensuring the integrity of non-EDC (Electronic Data Capture) clinical data.
Key Responsibilities
Develop and manage the DARS document specifying metadata and data transfer requirements
Oversee integration with external vendors, including labs and imaging partners
Support clinical trial platforms such as Rave EDC and Veeva EDC
Collaborate with cross-functional teams to meet deliverables and timelines
Import, clean, and maintain external data sets and ensure quality controls
Participate in system transformation projects, audits, SOP development, and regulatory filings
Act as a technical subject matter expert and liaison for system deliverables
Apply performance management, analytical, and problem-solving techniques in data handling
Required Knowledge and Skills
Deep understanding of Good Clinical Practice (GCP) and clinical trial operations
Experienced in external (non-EDC) data handling, data quality, and aggregation
Skilled in data acquisition tools, clinical database systems, and data lifecycle processes
Familiarity with programming languages and project management methodologies
Proven ability to lead cross-functional teams and oversee third-party vendors
Strong in systems development lifecycle, regulatory compliance, and risk analysis
Basic Qualifications
Bachelor’s degree in life sciences, computer science, or related field with 9–13 years of experience
Proven team leadership and project delivery in a clinical research setting
Experience in biotech, pharmaceutical, or CRO environments
Preferred Qualifications
Advanced degree (MS or equivalent) in relevant field
Broad domain experience in clinical data management and vendor integration
Strong communication and strategic thinking skills
Experience with large-scale system transformations and audits
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