Investigator Contracts Lead I- FSP (Dedicated to client office)
Senior
Description
<p><b>When our values align, there's no limit to what we can achieve.</b><br /> <br />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.</p><p>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.</p><p></p><p></p><p><b><u>Key Accountabilities</u></b><u>:</u></p><p></p><p>Contracting Deliverables</p><ul><li>Exercise sound judgment in balancing client risk with clinical trial timeline impacts when making budget and contractual decisions</li><li>Follow client-specific processes to develop, negotiate, track, and execute global clinical study agreements with institutions and investigators</li><li>Collaborate with internal and external partners to develop and oversee the global site budget process</li><li>Negotiate directly with clinical trial sites on cost, business, and contractual terms, making template adjustments within Legal-approved parameters</li><li>Lead study-level site contracting activities, guide other contract leads, and serve as the primary contact for site contracting issues and timelines on assigned studies</li><li>Partner with Legal and other departments to manage escalations related to site budgeting and contracting</li><li>Work with Legal, Finance, pCRO, and other stakeholders to identify and implement improvements in the site contracting process</li><li>Apply acquired job skills and procedures to complete assignments and projects of moderate scope and complexity</li></ul><p></p><p>Collaboration</p><ul><li>Build and maintain relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface</li><li>Collaborate with invoicing specialists and service providers to ensure alignment with site contracting and compensation requirements</li><li>Interface with site legal contacts, client legal teams, study management, site payments teams, peer contracting colleagues, and CRO contracting teams</li><li>Contribute to the design, development, and implementation of major business initiatives or special projects, applying technical expertise to support client objectives</li></ul><p></p><p>Skills and Competencies</p><ul><li>Strong balance of business, compliance, finance, legal, and drug development knowledge</li><li>Clear and precise communication and presentation skills</li><li>Ability to plan, identify, and mitigate risks to site contracting timelines</li><li>Capable of leading through influence rather than authority to achieve key deliverables</li><li>Proven success in a highly matrixed organizational environment</li><li>Fluency in written and spoken English is required</li></ul><p></p><p>Knowledge and Experience</p><ul><li>Experience with clinical study budgets and contract negotiation principles, practices, and processes</li><li>Understanding of core concepts and theories in relevant business disciplines</li><li>Preferred experience in drafting and negotiating Clinical Trial Agreements with global clinical trial sites</li></ul><p></p><p>Education</p><ul><li>Bachelor’s degree or equivalent with 5+ years of experience in clinical development operations or clinical trial outsourcing<br />OR</li><li>Juris Doctorate or equivalent with 2+ years of experience in clinical development operations or clinical trial outsourcing</li></ul><p></p>