When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel FSP is looking for Investigative Site Budget Specialist (ISBS) in Brazil!
The Investigative Site Budget Specialist (ISBS) is responsible for supporting the overall budget development process for site-facing budget templates, which includes working independently with business partners to develop global clinical site budgets, coordination of the multiple activities required to independently manage budget development to support clinical studies from start to close, serving as a key contributor for clinical contracts process improvement and quality initiatives related to the function, providing solutions-based expertise both internally and externally at a global level, and managing business partner interfaces to ensure the business achieves study start-up goals and effective deliverables.
Investigator Budget Build
Takes the lead role in development of site budgets for global utilization to ensure actionable, relevant budgets are provided to business partners on time
Accountable for drafting, reviewing and finalizing the creation of global clinical trial budget templates in accordance with Fair Market Value (FMV) and industry best practices
Amendment responsibilities as needed as protocol requirements mandate
Utilizes grant planning/industry cost benchmarking tools, International Classification of Diseases codes (i.e. ICD-9/10) and Current Procedure Terminology (CPT) codes to ensure standardization of budget template format
Monitors timelines for all clinical studies to ensure global budgets are built within study required timelines for both original and amended protocols and delivers to business partners on time
Supports business partner requests for ad hoc cost benchmarking analysis and global budget template development
Budget Oversight & Negotiation Support
Creates comprehensive parameters and tools for the Contracting Team to use for budget negotiations
Provides input into and supports global clinical site budgeting process and negotiation
Updates Master Budget Templates as appropriate in terms of benchmarks and exchange rates and continues to update budget templates to conform with internal budget negotiation parameters and in line with current industry trends
Updates the Master Investigator Fee Budget Template to align with internal processes and tools such as the new site payment system
Maintains documentation and database of approvals, including approvals for Master templates
Leadership
Serves as a Subject Matter Expert for cost benchmarking and cost benchmarking tools, providing internal training and ongoing support on a global level
Responsible for oversight of Investigator Budget Analyst staff including workload management, quality of deliverables and escalation of issues to management when needed
Supports the development and delivery of site budgeting process training and documentation, which includes contributing to the Clinical Contracts team onboarding plan and curriculum
Identifies training needs, formulates strategies to address training gaps, and conducts training as needed
Identifies and leads ongoing process improvement initiatives and training sessions related to the global site budget development process (including participating in pivotal initiatives), contributing to quality, systems and process initiatives
Onboarding, training, and mentoring peers with regard to site budgeting, including training the Clinical Contracts team on budget processes, Client best practice, and negotiation strategy
Responsible for development of process and acceptable guidelines for approvable budgetary requirements
Works on problems of diverse scope, as assigned by Manager/Director, where analysis of situations or data requires evaluation of identifiable factors
Collaborative Relationships
Works with Clinical Development Operations, Finance, Legal, the Site Contracting Team, Functional Service Providers, and Clinical Research Organizations (CROs) to ensure proper clinical trial budget development, training and dissemination occurs
Responsible and accountable for leading a meeting with Clinical and Global Site and Study Operations, Finance, Functional Service Providers, and/or CROs for budget delivery and explanation of the Master Template and/or parameters to ensure proper understanding to allow a high level of negotiation
Collaborates with and supports colleagues with the negotiation of site budgets and ancillary documents
Collaborates with Clinical and Global Site and Study Operations as needed for clarifications, providing education on the budget development process and rationale for items in the budget template
Knowledge And Experience
8+ years of professional work experience, including 5+ years in a research setting with pharmaceutical industry expertise in clinical contracting, outsourcing or finance is required
Demonstrates the qualifications needed to train and Quality Control (QC) the work of colleagues
Demonstrated ability in negotiation, project management, effective communication and relationship management
Demonstrates a high level of contract/budget and technical competencies across multiple therapeutic areas, which includes a high level of competence in negotiation and contracting/budgeting business standards
Contract negotiation experience in a scientific setting preferred
Demonstrated experience in contracts, budgets, clinical site/sponsor relationship and performance related to clinical drug studies preferred
Education
Bachelor’s degree or equivalent or relevant and qualifying training/experience
