Global Site Start Up Lead

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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

• Develop the site start up strategy for each study • Oversee the tracking and analysis of study metrics • Advocate for optimized site selection strategies • Lead the development, assessment, and alignment of site activation projections • Ensure comprehensive and compliant documentation of site start-up materials • Partner with cross functional and CRO partners to develop a comprehensive global country start up strategy • Monitor and maintain country intelligence data • Support regulatory submissions as needed • Ensure timely country submission deliverables • Lead and oversee all aspects of site start-up activities • Serve as the subject matter expert for essential site documents • Oversee CRO site start up management or in house site facing regional SSU team • Lead the collection and analysis of site intelligence • Oversee the preparation and approval of site regulatory package • Represent SSU on cross-functional teams • Recommends and participates in cross functional and department process improvements

🎯 Requirements

• 4-6 years of experience • Demonstrated interpersonal & leadership skills • Ability to understand and implement operational strategic direction for clinical studies • A data driven approach to planning, executing, and problem solving • Effective communication skills via verbal, written and presentation abilities • Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization • Ability to influence and negotiate across key stakeholders • Ability to build productive collaborations • 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 • Effective project management skills, cross-functional team interaction and organizational skills

🏖️ Benefits

• Competitive salary • Flexible working hours • Professional development budget • Home office setup allowance • Global team events