Global Site Start Up Lead

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Develop the site start up strategy for each study, outlining all dependencies impacting site activation • Oversee the tracking and analysis of study metrics, including risks and mitigation strategies • Advocate for optimized site selection strategies, leveraging data-driven insights • Lead the development, assessment, and alignment of site activation projections • Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) • Partner with cross functional and CRO partners to develop a comprehensive global country start up strategy • Monitor and maintain country intelligence data to support informed decision-making • Support regulatory submissions as needed • Lead and oversee all aspects of site start-up activities • Serve as the subject matter expert for essential site documents • Oversee the collection and analysis of site intelligence to support strategic site selection and site start-up • Represent SSU on cross-functional teams

🎯 Requirements

• 4-6 years of experience • Demonstrated interpersonal & leadership skills • A data driven approach to planning, executing, and problem solving • Effective communication skills via verbal, written and presentation abilities • Ability to influence and negotiate across key stakeholders • Experience in the clinical drug development process, with expertise in study start-up • Demonstrated vendor management experience • Technical proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel • Knowledge of ICH/GCP and regulatory guidelines/directives

🏖️ Benefits

• Health insurance • Remote work options