General Description:

The Senior Associate of Budget Development is responsible for the development of clinical site budgets and Fair Market Value (FMV) analysis for BeiGene sponsored clinical trials. This position partners with Global Clinical Operations (GCO), Investigator Contracts Management (ICM), and Data Management teams to establish clinical pricing for subject visits, procedures, and invoiceable expenses to inform site budget negotiations. The Senior Associate applies critical analysis and works in alignment with IPM and ICM leadership to develop country level site budget templates and internal/external negotiation parameters in accordance with BeiGene and industry guidelines. Under the remit of this position includes 1) providing data management analysis for Cost Per Patient (CPP) library and assessing, analyzing, and reporting budget discrepancies during evaluation and review of internal benchmark data to validate data integrity prior to stakeholder consumption 2) managing the New Study Notification and Protocol Assignment (NeSPA) project for CBO.

Experience with clinical site budget development and data evaluation and analysis:

• Solid understanding of Fair Market Value benchmarks and assessments.

• Working experience in utilizing CPT codes in the process of development of clinical trial budgets.

• Experience developing budgets for industry sponsored clinical trials.

• Experience in using Clinical Trial Management Systems (CTMS).

• Demonstrated experience in benchmark data analysis from clinical trial budgets.

Essential Functions of the job:

• Responsible for the development of global and region/country specific clinical trial budgets leveraging FMV benchmarking tool and established systems.

• Effectively partners with Clinical Operations to build global clinical site study budgets in compliance with all applicable policies, procedures, and objectives.

• Collaborate with Clinical Operations and Investigator Contracts Management teams on protocols requiring changes to site budgets.

• Create comprehensive new study budgets and budget amendments using FMV tool.

• 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 United States Medicare Coverage Analysis (MCA) guidelines for applicable studies and have a solid understanding of MCA requirements.

• Ability to analyze budgets and identify costs drivers where applicable.

• Ability to review and analyze complex protocol amendments and determine budget impact.

• Perform assessment and review of benchmark data for accuracy and report on outliers and discrepancies.

• Prepares ad hoc analysis relating to clinical site budget data.

• Assists in the preparation of data reports, training materials, business preparations and other educational materials.

• Collects new study information from Global Clinical Program Leads (GCPLs) and tracks new study information until Clinical Development Plan approval or removal from consideration.

• Manage NeSPA Smartsheet data, user access request, and perform ad hoc data pull from NeSPA lists.

Supervisory Responsibilities:

• None

Computer Skills:

Advanced knowledge Microsoft Office - Word, Excel, Power Point and MS Outlook; Smartsheets, SharePoint, MS Teams and Power BI

Other Qualifications:

• Fluent in written and verbal English.

• Excellent written and verbal communication skills and interpersonal relationship skills including relationship building and management skills.

• Demonstrated problem-solving and critical thinking skills, root cause analysis, attention to detail, and performance of duties.

• Prior experience in clinical operations, finance, or clinical pricing and/or payment position.

• Demonstrated experience using Grants Manager, Grant Plan or other equivalent Fair Market Value industry systems.

• Ability to meet critical timelines for budget development cycle-time.

• Ability to effectively communicate with stakeholders and provide guidance on costing for clinical site budgets.

Travel: As Needed

Education Required:

• BA/BS from accredited college or university and 3+ yrs. of industry experience or 4+ years in clinical research or

pharmaceutical industry

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.