Manager, Clinical Site Budgeting and Contracting

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Job Description

Objective / Purpose:

• Supports delivery of global site budgeting and contracting (SB&C) tasks, partnering with Sites, CRO 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 creative processes, methodologies, data, and technologies that will ensure ongoing improvements in the delivery SB&C services

Accountabilities:

• Manage negotiations, finalization and administration of Master Clinical Trial Agreements.
• 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.

Education & Competencies (Technical and Behavioral):

• BS degree or international equivalent
• 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.
• At least 2 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.

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