Global Clinical Study Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $118.6k - $158.6k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality • Lead all aspects of assigned clinical studies • Lead global cross-functional study teams, including oversight of external partners, and act as point of escalation for study issues • Ensure study goals align with clinical operations and corporate objectives • Manage external vendors and collaborate with regional subject matter experts • Provide regular study progress updates to senior management • Represent the study team at internal meetings and lead Clinical Study Team meetings • Lead planning and management from feasibility through closeout • Create, manage, maintain, and communicate study timelines • Oversee trial feasibility, allocation, and site selection across regions • Ensure timely availability of study documents for regulatory and ethics submissions • Oversee study start-up and site activation plans • Ensure study plans, systems, and tools are created, implemented, and maintained • Implement risk-based quality management processes and centralized monitoring analyses • Develop and implement study-specific training and maintain training records • Create, maintain, and quality-check the Trial Master File • Forecast study drug and coordinate timely delivery of supplies to sites • Support data cleaning timelines with Data Management and other stakeholders • Plan and execute the Clinical Study Report with Medical Writing and study team members • Monitor compliance with protocol, SOPs, study plans, ICH/GCP, and applicable regulations • Review and manage quality-related metrics and maintain inspection readiness • Identify study issues and ensure corrective and preventive actions are implemented • Communicate risks and challenges to senior management and implement mitigation plans • Prepare the team for quality assurance audits and inspections • Share cross-team, site learnings, and best practices • Lead process improvements and contribute to work instructions and SOPs • Select and manage study vendors and approve invoice payments • Manage study budgets, change control, closure budgets, accruals, and forecasts • Identify study team resource needs and monitor resource utilization • Ensure studies are executed within approved time, quality, and cost parameters

🎯 Requirements

• Proven project management experience in global clinical studies • Oncology experience preferred • Advanced knowledge of clinical operations methodologies • In-depth understanding of all aspects of clinical study processes • Ability to independently lead global clinical studies • 6 or more years of progressive experience in clinical research within biotech, pharma, or CRO industry • MS Office proficiency • Project planning applications proficiency • Clinical Trial Management Systems proficiency • Bachelor's Degree in a scientific or healthcare discipline required; higher degree preferred • Travel might be required as per business need

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards eligibility • Voluntary Employee Stock Purchase Plan participation • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid Time Off • Wellness benefits • Reasonable accommodation in the job application process