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The Manager, Strategic Research and Development Business Operations, holds a key support position within Business Operations acting as the Business Programs Site Manager (BPSM) for assigned programs. Under the leadership of the Site Contracts Functional Lead, the BPSM is responsible for managing the lifecycle of clinical trial site contracts and budgets from development to close-out. The Strategic R&D Business Operations (Business Operations) group is the center of excellence for providing industry best practice operational support for the conduct of BioMarin’s global clinical trials, including clinical vendor and site contract management, strategic vendor oversight, and clinical financial spend analysis and management. The group utilizes rigorous processes, procedures, and tools to ensure financial discipline and transparency in clinical vendor and trial site spend. The Manager, Development Science Business Operations will also contribute to the overall clinical portfolio business operations activities including vendor contracting management and financial management of clinical trials.
Job Responsibility:
Overall accountability for site-budget related financial management including executing on the global site budget and contracting strategy
Aligning with Global Study Operations on the clinical trial strategy
Primary point of contact (POC) for site budget and Clinical Trial Agreement (CTA) management
Develop clinical trial assumptions and program drivers and drive delivery of the milestones and metrics
Provide input into site selection and feasibility
Determine appropriate budget line items based on final protocol
Develop study/country/site budget template
Budget analysis and estimation
Proactively drive sites or CROs/vendors to reach agreement on budget line items
Draft country and site CTAs
Implement contracting process and negotiations
Ensure all contract versions are adequately tracked and filed
Process site amendments
Support and facilitate the reconciliation of site payments
Maintain awareness of country requirements
Supporting vendor/CRO performance oversight
Advise internal stakeholders on budget-related risks
Liaise with cross-functional departments
Requirements:
BA/BS in finance, accounting, health sciences, or related degree
8+ years of relevant experience working in the pharmaceutical industry (including CROs)
5+ years of relevant technical experience working within Clinical Operations or within Business Operations, including experience with clinical site and/or vendor contracts and budgets
Robust knowledge of site contracting and budgeting process U.S. and Rest of World
Demonstrates ability to effectively lead, develop and manage the lifecycle of the site contracting process for assigned programs with minimum oversight
Ability to plan, prioritize, and organize work timelines, resources, and tasks to support timely execution
Excellent written and oral communication skills
Experience and confidence collaborating with multiple functional areas and facilitating communication across multiple levels of internal/external teams to drive solutions
Demonstrates commitment to business ethics
Demonstrates resilience to change
can find solutions in challenging environments
Effective problem-solving skills
full analysis
searches for hidden problems
Nice to have:
Overall understanding of clinical site payments process and region-specific nuances
Good understanding of clinical trial protocols, in particular those sections that may impact site contracts and budgets