San Mateo, CA, 94497, USA
5 days ago
Manager, Site Budget Development - Japan & ROW
**General Description:** The Manager of Budget Development for Japan and ROW works independently and collaboratively within IPM to support Fair Market Value (FMV) analysis and site budget development. This position requires extensive knowledge and prior experience of the Japan point system for budget development. This role ensures that our site budgets for Japan are developed accurately, reflecting the scope of work and market conditions. The Manager of Budget Development leverages benchmark pricing data, historical pricing data for Japan sites, and sound financial judgement to determine budget line-item costs. Responsibilities include partnering with Global Clinical Operations (GCO), Investigator Contracts Management (ICM), and Data Management teams to establish clinical pricing for subject visits, procedures, and invoiceable expenses and managing the negotiation parameters for all Japan budgets that are in line with BeiGene’s financial goals. The Manager of Budget Development will be responsible for collaborating with the Japan Clinical Study team to develop, review, and finalize budgets for submission to sites and CROs and for leading the EDC/budget alignment discussions with Data Management teams and external partners to ensure accuracy in visit budget template development. **Essential Functions of the job:** + Under minimal guidance, responsible for the development of Japan and ROW clinical trial budgets leveraging Japan point system and FMV (for ROW) benchmarking tool and established systems. + Effectively partners with Global Clinical Operations to build global clinical site study budgets in compliance with all applicable policies, procedures, and objectives. + Collaborate with Global Clinical Operations and Investigator Contracts Management teams on protocols requiring changes to site budgets. + Develop, maintain, and train stakeholders on the global budget development documents and FMV tool assessments. + Actively and effectively communicates status of budget build with key internal stakeholders in a timely manner. + Effectively communicates issues to stakeholders that could impact project timelines or other aspects for Study Start Up (SSU). + Works closely with Clinical Operations, Contract Managers, Data Management to ensure successful development of study budgets. + Develops the most current and transparent budget that is in-line with industry standards. + Applies Japan point system budget development country requirements and the United States Medicare Coverage Analysis (MCA) guidelines for applicable studies and have a solid understanding of country regulatory requirements. + Ability to analyze Japan and ROW budgets and identify costs drivers where applicable. + Ability to review and analyze complex protocol amendments and determine budget impact. + Identify and participate in ongoing process improvement initiatives including new templates and processes. + Develop work instructions and process flows for Japan budget development. + Implement and deploy training and knowledge sharing with internal teams on Japan point system and budget development. + Maintain accurate and complete documentation of all Japan and ROW budgets. + Implement and adhere to all transparency regulatory requirements and FMV obligations globally. Additional Responsibilities and Requirements: + Act as point of contact for all IPM assigned studies. + Provide excellent customer service and timely site issue resolution. + Ability to problem solve and perform complex analysis by applying established guidelines and policies. + Demonstrates flexibility but follow organizational standards and processes where established. + Recommend latest ideas and solutions to increase efficiency of budget development. + Assist in the development and testing of CBO systems and standard processes. + Assist with maintenance of training and other manuals for the Grant system. + Organizes and prioritizes multiple initiatives across teams; sets clear plans for delivery. + Good organizational and time management skills. + Excellent communication / writing skills. + Self-motivation with the ability to work under pressure to meet deadlines. + Works well independently and in a team environment. + Detail and process oriented. + Positive attitude and approach. + Solid understanding of clinical cost benchmarking tools and CPT codes. + Demonstrates excitement in opportunities to participate in new projects and initiatives. + Assess potential risks and propose solutions to mitigate risks. **Supervisory Responsibilities:** + Yes **Computer Skills:** + Advanced knowledge Microsoft Office - Word, Excel, Power Point and MS Outlook; Smartsheet, SharePoint, MS Teams **Qualifications:** + Bachelor’s degree from an Accredited College + 5+ years’ experience in finance, biotech, pharmaceuticals, or a related field in the biotech/pharmaceutical industry + Fluent in written and verbal English. + Fluent in written and verbal Japanese is highly preferred. + Strong interpersonal skills, leadership, negotiation, analytical and problem-solving skills + Must be highly multi-tasked and meet compressed timelines. + Prior experience in budget development for Japan is a requirement for this role. + Experience in clinical operations, finance, or grant payment position. **Travel:** As Needed. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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