Local Study Associate Director – FSP

🕒 June 9

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Director

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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

• Leads Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines • Ensures that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived • Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits • Oversees, manages and coordinates monitoring activities from site activation through to study closure • Proactively identifies risks and facilitates resolution of complex study problems and issues • Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management

🎯 Requirements

• 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, budget and with required quality • Bachelor's degree in related discipline, preferably in life science, or equivalent qualification that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers • Must be fluent in English and local languages

🏖️ Benefits

• Competitive salary • Flexible working hours • Professional development opportunities • Health insurance • 401(k) matching