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Senior Manager, Clinical Program Management (CPM-SM) – Observational Research

WHAT YOU WILL DO

In this vital role, the CPM-SM in Observational Research (OR) will apply program management knowledge and Real-World Evidence experience as an operational lead overseeing the planning, design, execution, risk assessment and mitigations of several inhouse and/or fully outsourced observational research studies. These evidence generation studies span across all TAs and include various study types, complexities and novel operational models. A Senior Manager in CPO-OR is responsible for line management and maintaining close collaboration and alignment with internal stakeholders, such as: TA, Global Medical, CfOR, Operational and Safety stakeholders and external vendors and collaborators. In addition, the CPM-SM is consistently assessing the need for more fit for purpose processes to reflect innovative real world study designs and data collection methodologies.

ADDITIONAL RESPONSIBILITIES:

• Oversee people management, career development, training and succession planning of Amgen GTMs supporting the Observational Research Portfolio

• Support CPO resource planning for Observational Research portfolio in collaboration with CPO/OR Director, PRM and FSP Partners

• Oversee the operational execution, design, planning, risk assessment and mitigations of assigned inhouse and fully outsourced observational research studies.
• Oversight of assigned OR study specific budgets including change control in collaboration with TA Governance and Finance
• Point of issue escalation for Clinical Study Team on assigned studies.
• Ensure strong relationships and alignment with TA, GSO, CfOR, Safety, and HE representatives, maintaining and improving global collaboration and consistency
• Providing clinical operations leadership and expertise on the Product Teams (PTs) and AUEG (Access and Use Evidence Generation) Teams, as requested
• Support the identification of outsourcing requirements and the evaluation, selection, setup, and management of vendors for observational studies
• Contribute operational expertise ensuring operational feasibility throughout study design process, including KDE and Protocol Development
• Provide advice as requested on core study documents prior to Governance Body review
• Lead the Country Operational Landscape Assessments and study feasibility with Feasibility Director (study level) for inhouse managed observational research studies.
• Oversee and approve study global enrolment baselines and accurate global recruitment forecasting.
• Review and input into SOPs, Work Instructions, FORMS, templates and training for which CPO-OR are a stakeholder.
• Supporting continuous improvement initiatives in Clinical Program Operations (CPO) and Global Development Operations (GDO)
• Support and coordinate audit and inspection activities and contributes to CAPAs ensuring the update of processes.
• Communicate effectively with key team members to ensure operational strategy alignment.
• Contribute to functional goal setting as member of CPO-OR Leadership team and respective study level goals