Senior Manager, Site Start Up

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🟠 Senior

👔 Manager

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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

• Accountable for advancing study start-up activities for outsourced trials • Maintain timelines and successful execution with CRO partners • Manage all matters related to CRO partners study start-up requirements • Drive site activations through oversight of all activities • Lead day to day project activities in the matrix • Oversee start up activities with multiple CRO partners • Evaluate performance, solve challenges, monitor timelines and progress • Collaborating with functional colleagues for study completion • Review and approve start up plans for projects

🎯 Requirements

• Extensive pharmaceutical or related industry experience • Extensive previous experience of working in a Start-up team, Clinical Trial Specialist, CRA, Clinical Trial Manager or similar having worked on global clinical trials. • Experience in project management, CRO experience, change management or process design are beneficial • The candidate must have a good working knowledge of clinical operations, clinical processes and medical terminology. • Excellent knowledge of GCP and regulations • Experience of controlled drug substances processed would be beneficial • Experience of developing junior members of staff would be beneficial • Experience of Regulatory Inspections

🏖️ Benefits

• Health insurance • Retirement plans • Professional development opportunities