Local Study Associate Director – FSP

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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) at country level to deliver committed components of clinical studies • Ensures that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived • Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality • Leads and optimizes the performance of the Local Study Team(s) • Coordinates the site selection process by identifying potential sites/investigators • Reviews monitoring visit reports as required and advises the monitor(s) on study related matters • Proactively identifies risks and facilitates resolution of complex study problems and issues • 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 • Good knowledge of international guidelines ICH GCP as well as relevant local regulations • Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan • Excellent project management skills • Excellent team building and interpersonal skills • Excellent organizational skills • Excellent verbal and written communication skills • Proficient in written and spoken English language required • Fluency in local language(s) required

🏖️ Benefits

• Flexible working arrangements • Professional development

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