Study Start-Up Specialist – Site Activation Partner

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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

• Responsible for leading or supporting operational activities from start-up to close-out for assigned studies and investigator sites • Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation • Provide support to resolve issues or concerns and timely escalation of Site issues where applicable • Manage and coordinate with other supporting roles to ensure timely site activation and operational activities • Collaborate with in country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required • Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines • Identify and resolve investigator site issues

🎯 Requirements

• School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred • Minimum 2 years relevant experience in Clinical Trials environment and clinical site activation • Experience working in the pharmaceutical industry/or CRO is an asset • Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations • Must be fluent in Local language and in English. Multi-language capability is an asset

🏖️ Benefits

• N/A