Local Study Associate Director - FSP

đŸ”„ 0 minutes ago

đŸ—ŁïžđŸ‡Ș🇾 Spanish Required

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Logo of Parexel

Parexel

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

‱ Leads Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies. ‱ Ensures that sites are identified, qualifications performed, and documentation archived. ‱ Oversees and coordinates monitoring activities from site activation through to study closure. ‱ Develops, maintains, and reviews risk management plans on country study level.

🎯 Requirements

‱ Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies). ‱ Good knowledge of international guidelines ICH GCP as well as relevant local regulations. ‱ Excellent organizational skills. ‱ Excellent verbal and written communication skills. ‱ Proficient in written and spoken English language required. ‱ Fluency in local language(s) required.

đŸ–ïž Benefits

‱ Health insurance ‱ Flexible work arrangements ‱ Professional development opportunities

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