We are working closely with a key Medical Device company in Minneapolis that are hiring a Budget Analyst to join their team.

The Budget Analyst will conduct clinical trial site start-up activities related to the preparation of fair market value analyses and the creation of clinical study budgets while staying consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures.

Responsibilities:

• Work independently and proactively using the study protocol to conduct Fair Market Value Analyses and the creation of clinical study budgets using available databases and software packages.
• Prepare and distribute clinical study budget and supporting negotiation documents by gathering and analyzing information.
• Collaborate to develop and utilize sound financial processes.
• Track site level budgetary requests to provide insight into future budget negotiations.
• Manage large portfolio of budget related activities across several studies and division portfolios.
• Coordinate with clinical study teams to continually prioritize budget reviews as new information and/or considerations are introduced to keep pace with the overall service level targets.
• Develop and foster relationships to become a subject matter expert in the budget creation process.
• Critically review budget negotiations with clinical research sites to authorize escalations outside of fair market value.
• Develop, prepare, complete and track required budget documentation.
• Update and maintain budget information in Clinical Trial Management Systems as required.
• Escalate risks and/or initiate outreach to leadership, divisional clinical study leads and/or other stakeholders when appropriate.
• Ensure compliance with appropriate regulatory (ICH/GCP, FDA, IRB/EC, etc.) and internal SOPs/WI, policies & procedures.

Required Qualifications:

• Degree in Finance or Business or an equivalent combination of experience and education
• 2+ years’ experience in supporting clinical research
• Experience working with clinical trial management systems (e.g. Siebel CTMS) and clinical document control systems / eTrial Master Files
• Experience following standard operating procedures (SOP) and work instructions (WIs) in a quality environment.

Preferred Qualifications:

• Familiarity with diagnosis codes and medical coding practices
• Ability to work with multiple stakeholders at varying levels of the organization
• Expertise in using Grants Manager to develop study budgets
• Experience in supporting sites in multiple geographies

If this opportunity interests you please apply here.