Global Clinical Study Manager

This is a fully remote position, open to applicants in New York.

📋 Description

• Responsible for the global delivery of studies within established timelines and budgets while ensuring inspection readiness and quality.

• Oversees all facets of assigned clinical studies.

• Directs a global cross-functional study team, including the management of external partners, and serves as the escalation point for issue resolution within the assigned studies.

• Guarantees that study objectives align with clinical operations and corporate goals and objectives.

• Ensures the timely provision of high-quality study documentation necessary for submissions to regulatory bodies and ECs/IRBs.

• Monitors study activities to ensure adherence to the study protocol, standard operating procedures (SOPs), and all relevant regulations.

⛳️ Requirements

• Demonstrated Project Management experience in Global Clinical Studies (experience in Oncology is preferred).

• Extensive knowledge of clinical operations methodologies and a comprehensive understanding of all components of clinical study processes.

• Capable of independently leading global clinical studies (experience in pivotal study management is necessary).

• A minimum of 6 years of progressive experience in clinical research within the biotech, pharmaceutical, or CRO sectors.

• A Bachelor’s Degree in a scientific or healthcare discipline is required; a higher degree is preferred.

• Proficient in computer skills, including MS Office, project planning applications, and clinical trial management systems.

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness

• Opportunity to own shares of BeOne Medicines Ltd. stock

• Eligible to participate in the annual bonus plan for Non-Commercial roles