Local Study Associate Director – Oncology

🔥 13 hours ago

🇺🇸 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 to evaluate suitability and quality risks. • Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans. • Reviews monitoring visit reports and pro-actively advises the monitor(s) on study related matters. • Communicates and co-ordinates regularly with National Co-ordinating Investigator on recruitment and other study matters. • Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.

🎯 Requirements

• Minimum 3 years of experience in Development Operations leading clinical trials end to end in the US in a CRO or Pharma organization. • Direct experience in Oncology clinical trial management. • Good knowledge of international guidelines ICH GCP as well as relevant local regulations. • Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification (or equivalent adapted to local country market needs).

🏖️ Benefits

• Health insurance • Professional development opportunities