Manager, Clinical Site Contracts and Budgets - FSP

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 a Manager, Clinical Site Contracts and Budgets or Site Contracts Lead to join our growing team in Argentina! Candidates must have +5 years of contracts and budgets experience.

Job Overview

The Manager, Clinical Site Contracts and Budgets 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.

Key Accountabilities:

Oversight of activities:

• • 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 

• 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 

• 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 

Collaborative relationships:

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

Compliance with Parexel standards:

• Complies with required training curriculum

• Completes timesheets accurately as required

• Submits expense reports as required

• Updates CV as required

• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• +5 years of site budget and contract experience 

• Strong knowledge of site contracting practices and understanding of challenges 

• Demonstrated understanding of clinical operations and study start-up 

• Demonstrated experience with driving global site budget and contract strategies 

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

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

Knowledge and Experience:

• +5 years of site budget and contract experience 

• Strong knowledge of site contracting practices and understanding of challenges 

• Demonstrated understanding of clinical operations and study start-up 

• Demonstrated experience with driving global site budget and contract strategies 

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

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

Education:

• A bachelor’s degree is required  

• Juris Doctor or MBA preferred