AMAmgen Inc
System Administration Support
Hyderabad ₹4-8 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
