Role Summary
Manager, Site Budgeting and Contracting. Location: Massachusetts - Virtual (remote). This remote role reports to the Site Budgeting and Contracting leadership team and supports global SB&C tasks with Sites, CROs, and internal/external Study and Startup teams. The role focuses on budgeting, contracting, and enabling timely study startup and contract execution.
Responsibilities
- Supports delivery of global site budgeting and contracting (SB&C) tasks, partnering with Sites, CROs, and internal/external Study and Startup team members.
- Manage escalations and review of global site budgets and contracts from CRO partners to ensure timely contract execution and study startup forecasts are achieved.
- Drive negotiation and administration of Master Clinical Trial Agreements.
- Support the development of processes, methodologies, data, and technologies that will ensure ongoing improvements in the delivery SB&C services.
- Responsible for assigned study level SB&C function to develop, negotiate, administrate and execute assigned Clinical Trial Agreements and budgets.
- Oversight of budget setup including parameters for assigned studies.
- Partner with Study Start up Managers, CROs, Clinical Operations teams, and TAU partners to improve overall SB&C metrics and implement processes.
- Ensure standards are applied to the SB&C processes across project portfolios and support continuous improvement activities while developing TA-aligned strategies.
- Partner with Study Startup, CRO and Clinical Operations teams as an escalation point for global budget escalations outside of budget parameters.
- Leverage leading industry tools and data sources to provide budget and contract feedback aligned with Takeda parameters and fair market value guidance.
- Promptly recognize and improve potential delays providing solutions to resolve and escalate non-performance.
- Manage site contracts and budgets negotiation timelines to ensure sites are "Ready To Enroll" to the Startup Project Plan.
Qualifications
- 4 or more years of experience in clinical research site contracting and budgeting with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor.
- 2 or more years of global site budgeting and contracting oversight and/or negotiation.
- Ability to explain data, facilitate decision making processes to be data driven.
- Expertise in principles driving country/site budgeting and contracting strategies.
- Excellent organizational skills, decision making, communication and negotiation skills.
Education
- BS degree or international equivalent.
Skills
- Negotiation and administration of Master Clinical Trial Agreements
- Budget development and oversight for clinical studies
- Contract lifecycle management and escalation handling
- Stakeholder collaboration with CROs, Study Start up Managers, and Clinical Operations teams
- Data-driven decision making and analytics
- Strong organizational, communication, and negotiation abilities