Clinical Trial Oversight Lead - Northeast or Florida US - FSP
Parexel
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 preferred5+ 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 requiredProven experience in effectively communicating with site staff including Key Opinion Leaders (KOLs) and thought leadersCritical thinker who can review risk signals and apply to oversight activities at the site levelExperience in all study phases and experience in multiple therapeutic areasPrevious oversight and regulatory inspection experience preferredRisk-based monitoring experience preferredDemonstrates flexibility in schedule and wiling to travel frequently in assigned regionGood organizational skills and ability to deal with competing prioritiesEffective communication skills (written, verbal and presentation)Proficient with MS Office Suite (Excel, Word, and PowerPoint)Language Skills:
Proficiency in written and spoken EnglishProficient in local language, as applicableFluent in multiple languages and cultural awareness is a plusTravel Requirements:
Ability to travel anticipated to be 40-60%#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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