Investigator Contracts Lead - FSP (Site Contracts Lead)

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.

Key Accountabilities: 

Contracting deliverables 
Exercise good judgment in balancing the risks to the client in making budget and contractual decisions against the impacts to client clinical trial timelines  

Follow client processes to develop, negotiate, track and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials  

Work with partners to develop and oversee the global site budget process  

Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters  

Lead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studies 

Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space  

Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space  

Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline 

Collaboration 
Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface  

Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements 

Interacts with clinical site contracts & legal contacts, client and partner legal team, study management, site payments team, peer site contracting colleagues, CRO site contracting teams  

Contributes to design, development and implementation of major business initiatives or special projects. Applies technical skills and discipline knowledge to contribute to achievement of client business objectives 

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:  
Balance of general business, compliance, finance, legal, and drug development experience  

Precise communications and presentation skills  

Ability to plan, identify and mitigate risks to site contacting timelines  

Ability to lead by influence rather than positional power to accomplish critical deliverables  

Success in working in a highly matrix based organization  

Fluency in written and spoken English is required  

Knowledge and Experience:  
Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities  

Knowledge of the principles, concepts and theories in applicable business discipline  

Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation preferred  

Education:  
Bachelor’s Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR  

Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing