Global Site Start Up Lead – FSP

🔥 51 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

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

• Accountable for the global execution of site activation for assigned clinical trials • Develop the site start-up strategy for each study • Oversees the tracking and analysis of study metrics • Advocate for optimized site selection strategies • Ensure comprehensive and compliant documentation of site start-up materials • Partner with cross functional and CRO partners • Monitor and maintain country intelligence data • 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 • Represent SSU on cross-functional teams • Recommend and participate in cross functional and department process improvements • May require up to 25% travel

🎯 Requirements

• 4-6 years of experience • Demonstrated interpersonal & leadership skills • Ability to understand and implement operational strategic direction • A data-driven approach • Effective communication skills via verbal, written and presentation abilities • Proactive and self-disciplined • Ability to influence and negotiate • Experience in the clinical drug development process • Demonstrated vendor management experience • Technical proficiency in trial management systems (CTMS, TMF) and MS applications • Knowledge of ICH/GCP and regulatory guidelines/directives • Effective project management skills

🏖️ Benefits

• Paid time off • Professional development opportunities