[Hiring] (Senior) Associate, Clinical Site Budget Planning @BeiGene

Role Description

The (Senior) Associate 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. Works under limited supervision and guidance. Serves as a subject matter expert in the site budget development, able to identify and resolve issues that arise. Able to lead complex site budget development and analysis.

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 for submission to BeOne governance committees (e.g. Development Review Committee (DRC), Clinical Finance Review Committee (CFRC)) for financial planning, forecasting, and data-driven strategic decisions 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 cost drivers of budget variances from prior site budget version.
• Lead complex site budget development and analysis.
• Provide strategic insight, when required, into budget development 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 track and effectively communicate status of site budget development with CBO leadership and key internal stakeholders in a timely manner.
• Coordinate 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 communicate issues to stakeholders that could impact project timelines or other aspects of SSU.
• Contribute to 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.
• Conduct peer quality control (QC) checks of site budgets.
• 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.

Qualifications

• Bachelor’s degree from an accredited college or university.
• 3+ years’ experience in finance, business, clinical research or related field in the biotech or pharmaceuticals industry.
• Fluent in English with excellent communication and writing skills.
• Strong interpersonal, analytical, numerical and problem-solving skills.
• Good organizational skills with the ability to manage multiple deliverables and competing priorities.
• Detail and process oriented.
• Capable of working independently or in a team environment.
• Solid understanding of FMV benchmarking tools and CPT codes.
• Proficiency in site budget development, analysis and modelling techniques.
• Prior experience in clinical operations, finance, site contract or site payment positions.
• Understanding of ICH GCP guidelines and clinical research processes.

Computer Skills

• Advanced knowledge of Microsoft Office software - Word, Excel, Power Point and MS Outlook.
• Smartsheet, SharePoint, MS Teams.

Travel

• As needed.

Benefits

• Market competitive compensation package including performance-based annual bonus scheme.
• Company shares (generous welcome grant!).
• In-house and external learning and development opportunities.
• Fantastic benefits program and keep improving!
• Work with a dynamic team of collaborative, supportive, inclusive, and fun professionals.

Company Description

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S.