1 - 4 years
1 - 4 Lacs
Hyderabad / Secunderabad, Telangana, Telangana, India
Posted:1 day ago|
Platform:
On-site
Full Time
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 manage the Rave EDC Platform. This role requires a highly organized, proactive and detail-oriented professional to manage 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 party vendor team for all Rave upgrades and custom script validation Coordinate the 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 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: Masters degree and 4 to 6 years of related experience Bachelors 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
Amgen Technology Private Limited
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