- 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, including agenda and meeting minutes.
- Coordinate and provide oversight of Rave User Access for all studies and Rave URLs.
- Potential evaluation of other EDC systems, e.g., Veeva System.
- Maintain standard business processes within GDO Systems to ensure compliance with regulatory bodies.
- Coordinate activities with the 3rd-party vendor team for all Rave upgrades and Custom script validation.
- Coordinate cross-functional teams for testing activities for all impacted downstream systems for Classic Rave and Rave EDC releases.
- Act as a liaison between Rave R&D stakeholders related to all systems used for Rave access, focusing on the design of new functionality based on business or regulatory changes.
- Act as a technical point of contact to work with the DTI team to manage enhancements to systems used by R&D stakeholders, e.g., STAR, DMP.
- Provide technical and business process input/expertise for the adoption of automation and/or new technologies for existing systems.
- Manage all document creation and/or updates 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.
- Confidentiality & Professionalism:
- Handle sensitive and confidential information with utmost discretion.
- Act as a gatekeeper to ensure alignment with executives' priorities.
- Master's degree and 4 to 6 years of related experience
- OR
- Bachelor's degree and 6 to 8 years of related experience
- OR
- Diploma and 10 to 12 years of related experience
- 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 Rave User access and EDC release validation.
- Continuous optimization and streamlining of 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.
- 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).
- 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.
- 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.
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System Administration Support - Hyderabad / Secunderabad, Telangana - Amgen Technology Private Limited
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. This role coordinates cross-functional activities to manage the Rave EDC Platform and requires a highly organized, proactive, and detail-oriented professional with the ability to manage multiple projects and meet timelines.
Roles & Responsibilities
Basic Qualifications and Experience
Functional Skills
Must-Have Skills
Good-to-Have Skills
Soft Skills
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