General Description:The Manager of Budget Development works independently and collaboratively within IPM to support Fair Market Value (FMV) analysis and site budget development. 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. The Manager of Budget Development will be responsible 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 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.
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 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.
Identify and participate in ongoing process improvement initiatives including new templates and processes.
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.
Strong interpersonal skills, leadership, negotiation, analytical and problem-solving skills
Must be highly multi-tasked and meet compressed timelines.
Prior 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.