***Immediate Opening for a Manager, Clinical Budget Development ****
***MUST BE ON EST TIME ZONE**
***Will be required to travel on-site to NJ for important meetings quarterly***
The Manager, Clinical Budget Development will serve as a subject matter expert in the development of global clinical trial budgets. The role will frequently collaborate with R&D, Purchasing, and Finance business teams including Financial Analysts, Legal, Clinical Payments, and Site Management teams to develop robust and comprehensive clinical site budgets. The role will also be expected to ensure that budgets are compliant with study protocol requirements, aligned with overall budget projections and consistent with Fair Market Value (FMV) via the benchmarking tool, GrantPlan.
Job Responsibilities:

• Provide operational expertise, leadership, and support to teams on all aspects of clinical budget development.
• Develop, negotiate, and coordinate transparent clinical trial budgets for both large and small sites in line with industry standards, and analyze existing budgets to identify cost drivers, where applicable.
• Partner with R&D to build global clinical site budgets in compliance with all applicable policies, procedures, and corporate objectives.
• Assist in the management of both Sponsor and CRO clinical budget analyst staff.
• Develop and maintain global budget development documents including the Exhibit A and other FMV tool assessments.
• Review research protocol and related documents to assist with budget development; serve as the first line of contact to Client stakeholders to provide insight into the clinical budget development process with challenging and unique protocols (protocol complexity, underrepresented participant populations, etc.).
• Independently create global and country-specific clinical trial budget templates and FMV benchmarks by using clinical budgeting tools and systems (ie. GrantPlan, ClearTrial, MediDate, Conga, SharePoint, etc.) and subsequent negotiation.
• Apply and understand the United States Medicare Coverage Analysis (MCA) guidelines for applicable therapeutic areas.
• Update key internal and external stakeholders with budget creation status and escalate issues that could impact project timelines or other aspects of study start-up.
• Identify quality improvement opportunities to facilitate processes related to budgets and other associated services.
• Work closely with Clinical Management leadership, Study Project Manager, Clinical Trial Associates, Therapeutic Area leads, Legal, OUS stakeholders, Contracts Managers, and Clinical Payments.

Additional Skills & Qualifications:

• Bachelor's degree is required; Science or Finance degree is preferred.
• Minimum of 5 years' experience in the management and independent development of clinical trial budgets
• Global clinical budgets experience is required (i.e. United States, Canada, EU, UK, and Australia)
• Expertise with GrantPlan and FMV analysis
• Familiarity with regulatory requirements and guidelines for clinical trials (e.g. FDA regulations, ICH GCP guidelines).
• Excellent organizational and time management skills, with the ability to prioritize tasks effectively.
• Strong interpersonal and communication skills, with the ability to work collaboratively in a team environment.
• Ability to maintain confidentiality and handle sensitive information appropriately.
• Up to 15% travel.

Experience Level:
Expert Level
About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.