#R-228339
bservational Research (CfOR). This role will work with other Amgen teams to oversee and drive execution of CfOR's operational projects and non-interventional studies ensuring timely completion within budget and at the highest quality. This role requires strong project management capabilities combined with a growth mindset and openness to leveraging emerging AI tools to improve productivity and drive CfOR-wide initiatives.
Key Responsibilities:
Provide specialized support to a team of Observational Research Scientists specializing in real-world evidence projects in multiple regions
Provide comprehensive document requirement support, mainly to a team of Observational Research Scientists specializing in real-world evidence studies across the globe
Support adoption and integration of platforms such as Smartsheet, AI, Microsoft Teams, and Miro to enhance team collaboration and project tracking
Support strategic initiatives, including operational pilots, change management efforts that elevate CfOR's organizational capabilities
Contribute to department/unit by ensuring quality of tasks/services provided
Communicate status and issues effectively to appropriate parties, both within CfOR and across Amgen
Assist leaders with study start-up and study close-out processes
Identify and implement process improvements through automated technology to increase efficiency, reduce cycle time and replace manual operations
Create, analyze, and maintain process flow diagrams to ensure efficient and effective operational workflows
Track and reconcile study milestones and deliverables, ensuring accurate data population in internal systems
Conduct regular meetings with study leads to discuss operational activities
Identify potential department/cross functional process improvement activities
Execute financial transactions, including purchase order processing, invoice verification, payment processing, and engaging with other functions to help plan and manage resource expenses, using Anaplan, Ariba or SAP software
Basic Qualifications:
Bachelor's degree and 6+ years of Scientific or Operations experience OR
Master's degree and 4+ years of Scientific or Operations experience
Preferred Qualifications/Skills:
Minimum of 3 years of project management experience, with 2+ years in pharma/biotech within regulated, cross-functional environments
Hands-on experience with budgeting, vendor management, and regulated document management systems
Demonstrates autonomy and reliability in managing tasks and contributing to team goals
Highly organized, with the ability to prioritize and deliver on projects independently or collaboratively
Quick learner with strong analytical skills and adaptability to new tools and concepts
Effective communicator with strong written, verbal, and presentation abilities
Builds positive relationships and fosters collaboration with a proactive, "can-do" attitude
Demonstrated proficiency & adaptability with related software tools (ChatGPT, Copilot, Smartsheet, Miro, SharePoint, MS Teams, Office 365, etc.)
Familiarity with drug commercialization & business practices
Comprehensive understanding of Good Clinical Practices (GCP), FDA regulations, and applicable regulatory/compliance frameworks critical to clinical and commercial operations
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