Mgr. Clinical Pricing

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Operations
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Job Description

ABOUT 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.

Accountabilities

•Provide oversight and direction across clinical pricing, site budgeting, site contracting support and clinical trial payment activities to enable timely Study Start-Up and ongoing study delivery.

•Ensure pricing, finalized site budget, contracting and payment activities are delivered to expected quality and timelines, with accurate information maintained to support downstream processes, systems and reporting.

•Lead and coordinate a Regional Clinical Pricing & Payments support team, partnering with Study Start-Up, Clinical Study Teams, Finance, Law, Data Management, Site Management and other stakeholders to support effective progression from budget design through contracting and payment execution.

Responsibilities

•Provide oversight of clinical pricing, budget and payment set-up activities for assigned countries, ensuring activities are delivered to support Study Start-Up and ongoing study delivery.

•Plan and allocate team resources and priorities to effectively manage pricing, payment, system configuration and reporting workloads.

•Oversee study-level payment system set-up, including study configuration, payment triggers, budget mapping and related activities, ensuring appropriate procedures are followed by the team.

•Provide oversight of day-to-day Clinical Trial Payment System (CTPS) operations and ensure payment processing service-level commitments, quality standards and performance targets are met.

•Ensure site configuration packages and subsequent payment-system change requests are completed accurately and within required timelines, including changes resulting from site budget, contract or protocol amendments.

•Oversee the approval of manual payment requests and site invoices within CTPS and approve payment requests and invoices directly when required.

•Oversee monthly variable payment allocation activities for applicable countries and ensure payments are appropriately processed in accordance with established requirements.

•Oversee data-quality and validation checks on finalized site budget information uploaded to CTPS and ensure identified discrepancies are investigated and resolved.

•Ensure CTPS user access requests and other required payment-system administration activities are processed accurately and appropriately.

•Investigate and resolve escalated invoice and payment queries, providing direction to the team and coordinating with relevant stakeholders where additional action is required.

•Liaise with the CTPS vendor to ensure site payment timeliness and accuracy and to coordinate resolution of escalated site, payment and system issues.

•Oversee payment reconciliation activities and ensure payment-system close-out activities for clinical trial sites are completed accurately and within required timelines.

•Ensure appropriate tracking and reporting of clinical pricing and payment activities, including operational performance, service levels, outstanding actions, risks and escalations.

•Provide oversight and direction to staff supporting pricing, payment processes and reporting requirements, ensuring procedures are followed and work is completed to expected quality and timelines.

•Provide oversight of operational and administrative activities supporting site contracting, ensuring required information, documentation and associated activities are progressed in alignment with study and site timelines.

•Partner with Clinical Study Teams, Study Start-Up, Finance, Law, Data Management, Site Management and other stakeholders to support effective progression from budget design and site contracting through payment set-up and ongoing study delivery.

•Identify opportunities to simplify, standardize or automate activities, and coordinate or support process improvement, CAPA and cross-functional initiatives as required.

Continuous Improvement

•Identify opportunities to simplify, standardize or automate activities.

•Develop/share templates, tools, best practices and lessons learned.

•Support CAPA implementation and continuous improvement across studies.

•Co-ordinate and support project/process improvement activities

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.

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