Site Activation Partner I

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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 to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Client standards. • Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation • Register investigator sites and Client stakeholders in Client registries and systems as required. • Work directly and interact with investigator sites to confirm readiness for site start-up • Prepare, validate and submit regulatory documents for internal regulatory approval within required timelines • Ensure maintenance of IRB/Ethics and other committees’ activities as applicable • Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study • Collaborate with the Study Team on the development and readiness of sites electronic Investigator Site File (eISF) • Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests

🎯 Requirements

• Minimum 3 years’ relevant experience in clinical site management, working with US/Canada. • Experience working in the pharmaceutical industry/or CRO in study site activation is preferred • Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization • Good technical skills and ability to learn and use multiple systems • Demonstrated knowledge of clinical research and development processes, Key operational elements of a clinical trial, and ability to gain command of process details • Attention to detail evident in a disciplined approach • Ability to work independently and also as a team member • Ability to organize tasks, time and priorities, ability to multi-task • Understand basic medical terminology, GCP requirements and proficient in computer operations • Must be fluent in Local language and in English. Multilanguage capability is preferred

🏖️ Benefits

• Flexible work arrangements • Professional development