Brief Description:

The position will be responsible for drafting, negotiating, and implementing global investigative site budgets and contracts for assigned studies, including reviewing sites’ proposed changes/requests, to ensure the timely and compliant delivery of site clinical trial agreements while developing and maintaining positive relationships with Jazz’s investigative sites.  The role will involve collaborating with stakeholders internally as well as with external partners.

Essential Functions/Responsibilities

• Serve as the site contracts and budgets lead across assigned studies accountable for ensuring the timely, high quality and compliant execution of the site budget and contract negotiation process

• Collaborate with key stakeholders on the study team from early planning and throughout the contract lifecycle to prioritize, plan and execute in alignment with operational objectives

• Actively and regularly drive prioritization and progress on site contracts within the clinical trial working group

• Develop or oversee budget setup including study-specific parameters for assigned studies using industry tools and data sources

• Manage site contracting related issues efficiently and according to escalation pathways

• Communicate effectively internally and with external partners to ensure alignment and excellence in coordination of study start-up activities (i.e. SIV scheduling)

• Ensure that all relevant systems and trackers are accurate and timely with regard to the disposition of site budgets and contracts

• Apply standards to the site budgeting and contracting process across studies/programs

• Manage all changes to study scope ensuring timely implementation of amendments

• Partner with Legal, Compliance and other collaborating functions on continuous improvement to site budgeting and contracting processes

• Lead site budget and contract process improvement initiatives, as required

• Manage against study-level KPIs and metrics for site budget and contract negotiation

• Train and mentor peers and stakeholders, as required

• Provide oversight, leadership and operational management of FSP resources.

Required Knowledge, Skills, and Abilities

• Five or more years site budget and contract experience

• Demonstrated excellent verbal, written, and interpersonal communication skills.

• Demonstrated understanding of regulatory and legal issues related to the conduct of clinical trials

• Demonstrated experience with driving global site budget and contract strategies

• Strong knowledge of site contracting practices and understanding of challenges

• Strong relationship building, negotiation, and conflict resolution skills

• Demonstrated understanding of clinical operations and study start-up

• Familiar with common budget development and data tools (e.g. Grant Plan)

Required/Preferred Education and Licenses

• A bachelor’s degree is required

• JD or MBA preferred

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