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The Manager, Csar - Electronic Data Interchange And Acquisition

9-13 years
Not Disclosed
10 May 1, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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