AM

System Administration Support

Amgen Inc
Hyderabad4-8 LPA Posted 8 May 2025
FULL TIME
clinical trial platform technologies
EDC systems
EDC vendor
Rave EDC FMT meetings
Rave EDC System
+1 more

Job Description

About the Role

Role Description:

The Manager will support the oversight of Rave EDC user access and management of Classic Rave and Rave EDC system upgrades for all Rave URLs. This role involves coordinating cross-functional activities to manage the Rave EDC Platform effectively. It requires a highly organized, proactive, and detail-oriented professional capable of managing multiple projects and meeting timelines.

Roles & Responsibilities

Technical Support / Project Coordination:

  • Provide support for clinical trial platform technologies related to the Rave EDC System
  • Work with the EDC vendor to translate business issues/requirements into technical solutions
  • Manage Rave EDC FMT meetings, including agenda setting and meeting minutes
  • Coordinate and oversee Rave User Access for all studies across all Rave URLs
  • Evaluate potential use of other EDC systems, e.g., Veeva System
  • Maintain standard business processes within GDO Systems to ensure regulatory compliance
  • Coordinate with third-party vendors for Rave upgrades and custom script validation
  • Collaborate with cross-functional teams for testing downstream systems affected by Classic Rave and Rave EDC releases
  • Act as a liaison between R&D stakeholders and systems for Rave access and design of new functionality due to business or regulatory changes
  • Serve as a technical point of contact with the DTI team to manage enhancements to systems (e.g., STAR, DMP)
  • Provide technical and business process input for automation and new technology adoption
  • Manage document creation and updates related to Rave User Access, including for acquisitions (e.g., Horizon)
  • Conduct risk assessments for evaluation of alternative EDC systems (e.g., Veeva)

Confidentiality & Professionalism:

  • Handle sensitive and confidential information with discretion
  • Act as a gatekeeper to ensure alignment with executive priorities

Basic Qualifications and Experience

  • Master's degree and 4 to 6 years of related experience
  • Bachelor's degree and 6 to 8 years of related experience
  • Diploma and 10 to 12 years of related experience

Functional Skills

  • Management and operational oversight of GDO systems, platforms, and tools (e.g., EDC)
  • Ensure quality and timely operational delivery of system activities supporting EDC platform upgrades
  • Lead or participate in the development, review, and implementation of processes, SOPs, and policies affecting GDO
  • Drive continuous improvement in Rave User Access and EDC release validation processes
  • Optimize Rave EDC release validation using AI and automated technologies
  • Respond to R&D stakeholder inquiries related to Rave User Access and manage the EDC mailbox

Must-Have Skills

  • Strong technical and analytical skills with the ability to manage multiple projects
  • Exceptional attention to detail and accuracy in deliverables
  • Ability to work independently and proactively in a fast-paced environment
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
  • Familiarity with virtual collaboration tools (e.g., Teams, WebEx)

Good-to-Have Skills

  • Knowledge of pharmaceutical industry terminology
  • Experience working in a multinational environment with global teams
  • Familiarity with project management tools and methodologies
  • Basic understanding of compliance and data privacy requirements

Soft Skills

  • Excellent verbal and written communication skills
  • High degree of professionalism and interpersonal skills
  • Strong problem-solving abilities and adaptability to changing priorities
  • Resilience, discretion, and ability to thrive under pressure

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