System Administration Support
System Administration Support
India - Hyderabad Apply NowABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
ABOUT THE ROLE
Role Description:
The Manager will support the oversight of the Rave EDC user access and management of the Classic Rave and Rave EDC system upgrades for all Rave URLs. Coordinate the cross functional activities to mange the Rave EDC Platform. This role requires a highly organized, proactive and detail-oriented professional to mange and execute these activities. Ability to manage multiple projects and meet the timelines.
Roles & Responsibilities:
Technical Support/Project Coordination:
Support of clinical trial platform technologies for the Rave EDC System
Ability to work with the EDC Vendor on translating business issues/requirements into technical solutions
Manage the Rave EDC FMT meetings, agenda, meeting minutes, etc.
Coordinate and provide oversight of the Rave User Access for all studies for all Rave URLs
Potential evaluation of other EDC systems, e.g. Veeva System etc.
Maintain standard business processes within GDO Systems to ensure compliance to regulatory bodies
Coordinate the activities with the 3rd part vendor team for all Rave upgrades and Custom script validation.
Coordinate the cross functional teams for testing activities for all impacted downstream system for Classic Rave and Rave EDC releases
Act as a liaison between Rave R & D stakeholders related to all systems used for the Rave access related to design of new functionality based on changes in the business or regulatory agencies
Act as a technical point of contact to Work with DTI team to manage enhancements to systems used by R&D stakeholders, e.g. STAR, DMP, etc.
Provide technical and business process input / expertise for adoption of automation and/or new technologies for existing systems.
Manage all document creation and/or updates to documents related to Rave User access including acquisitions, e.g. Horizon
Ability to evaluate and conduct risk assessment for potential other EDC systems, e.g. Veeva System etc.
Confidentiality & Professionalism:
Handle sensitive and confidential information with utmost discretion.
Act as a gatekeeper to ensure alignment with the executives' 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 system, platforms and tools (e.g., EDC,)
Ensure quality and timely operational delivery of systems activities supporting EDC platform upgrades
Lead or participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting GDO
Continuous improvement of processes for the Rave User access and EDC release validation
Continuous optimization and streamlining of the Rave EDC Release validation including the implementation of new AI /Automated processes
Ability to assist R&D Stakeholders inquiries regarding Rave User Access and managing 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 all deliverables.
Ability to work independently and proactively in a fast-paced environment.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and 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 the ability to thrive under pressure
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
