Manager, Clinical Site Budget Planning

General Description: The Manager is responsible for the development of accurate and compliant investigator grants (“site budgets”) that facilitate trial-level financial planning and forecasting activities and guide fair market value (FMV) negotiations with clinical sites for BeOne-sponsored clinical trials. This role requires a high degree of independence and expertise in site budget development, enabling the identification and resolution of arising issues, and the leadership of complex budget builds and analysis. The Manager acts as the primary subject matter expert (SME) for budget development processes and templates specific to a designated country(ies), ensuring that site budget development accurately reflects the country’s requirements and market conditions. Leverages internal and external benchmark pricing data, historical pricing, and sound financial judgement to determine appropriate local activity pricing and parameters. Effectively collaborates with local stakeholders (Clinical Site Contracts, Clinical Operations, Clinical Site Payments, Data Hub, Compliance) to support alignment and optimization of budget development processes and templates. Provides training and supports query resolution on budget development for the designated country(ies).

Essential Functions of the Job:  Responsible for the development of trial-level and country-level site budgets that are in line with industry standards and local requirements, leveraging FMV benchmarking tools, BeOne Rate Cards, established systems, databases and processes.  Work effectively with Clinical Operations (i.e. Clinical Study Managers (CSM), Clinical Project Lead (CPL), Clinical Site Contract Managers (CM), etc.) and relevant stakeholders (i.e. Medical Directors, Global Research & Development Sourcing (GRDS), R&D Finance, etc.) to build site budgets in compliance with the study protocol requirements, study assumptions, applicable policies, procedures, and objectives.  Provide site budget deliverables: a) for submission to BeOne governance committees (e.g. Development Review Committee (DRC), Clinical Finance Review Committee (CFRC)) for the purpose of financial planning, forecasting, and data-driven strategic decisions for the study/trial; and/or b) to Clinical Operations (CSM and CM) to support efficient and compliant FMV negotiations with clinical sites for the study/trial.  Serve as a member of the BeOne Estimate Support Team (BEST), providing site budget estimates throughout the protocol life cycle (from inception to close-out of the clinical trial) for financial planning and forecasting. Perform budget variance analysis, scenario modeling, and benchmark assessments to support strategic decision-making of the business.  Work on assigned site budget requests from internal stakeholders for a study/trial.  Analyze protocol amendments and/or changes to trial/study assumptions, to determine impact to site budgets, identify costs drivers of budget variances from prior site budget version.  Lead complex site budget development and analysis. Assess potential risks and propose solutions to mitigate risks.  Provide strategic insight into budget building process with difficult protocol situations (complex protocols, difficult therapeutic areas with high priority studies).  Organize meetings with stakeholders to resolve queries, obtain required information and approvals in order to drive the timely development of accurate site budgets.  Actively tracks and effectively communicates status of site budget development with CBO leadership and key internal stakeholders in a timely manner.  Coordinates with internal stakeholders to ensure study start-up (SSU) activities are aligned with site budget activities and mutually agreed upon timelines for site activation. Effectively communicates issues to stakeholders that could impact project timelines or other aspects of SSU.  Recommend ideas and solutions to increase efficiency of site budget development.  Organizes, prioritizes and leads multiple process improvement initiatives, including but not limited to, development and training for new site budget templates, updates to guidance, processes, checklists, trackers, tools, knowledge sharing, etc. and sets clear plans for delivery.  Conduct peer quality control (QC) checks of site budgets.  Triage group mailbox, coordinate assignments and address queries related to site budget development.  Mentor, train and support junior associates in budget development processes  Develop, maintain, and train stakeholders on budget development documents and processes.  Undertake other duties as requested by departmental and company leadership.

Computer Skills:  Advanced knowledge Microsoft Office software - Word, Excel, Power Point and MS Outlook; Smartsheet, SharePoint, MS Teams Other Qualifications:  Fluent in English with excellent communication and writing skills. Fluent in a second language to support collaboration with local stakeholders in the development of local budget templates, processes, guidelines and training.  Exceptional analytical, numerical and problem-solving skills.  Effective leadership and interpersonal skills, able to collaborate and drive change management.  Excellent organizational skills with the ability to manage multiple deliverables and competing priorities.  Detail and process oriented.  Extensive experience in site budget development, analysis and modelling techniques.  Expertise in FMV benchmarking tools and CPT codes.  Prior experience in clinical operations, finance, site contract or site payment positions.  Strong understanding of ICH GCP guidelines and clinical research processes. Travel:  As needed

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