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Clinical Trial Oversight Lead
3 weeks ago
When our values align, there's no limit to what we can achieve.
Parexel is seeking a Clinical Trial Oversight lead in the Northeast US or in Florida
Position Purpose:
The Clinical Trial Oversight Lead (CTOL) is responsible for the following:
Organizational Relationships:
Reports to Functional Service Provider (FSP) Line Management with day-to-day direction from the Client
Primary Responsibilities:
Education and Certification:
Bachelor’s Degree is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD) is preferred 5+ years of relevant experience with 3+ years of direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferredSkills and Experience:
Risk Based Quality Management experience required Proven experience in effectively communicating with site staff including Key Opinion Leaders (KOLs) and thought leaders Critical thinker who can review risk signals and apply to oversight activities at the site level Experience in all study phases and experience in multiple therapeutic areas Previous oversight and regulatory inspection experience preferred Risk-based monitoring experience preferred Demonstrates flexibility in schedule and wiling to travel frequently in assigned region Good organizational skills and ability to deal with competing priorities Effective communication skills (written, verbal and presentation) Proficient with MS Office Suite (Excel, Word, and PowerPoint)Language Skills:
Proficiency in written and spoken English Proficient in local language, as applicable Fluent in multiple languages and cultural awareness is a plusTravel Requirements:
Ability to travel anticipated to be 40-60% EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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