Associate Director, Global Clinical Study Management

🔥 5 minutes ago

🇺🇸 United States – Remote

💵 $143.3k - $193.3k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 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, budget, and inspection-readiness quality • Lead all aspects of assigned global clinical studies • Lead global cross-functional study teams and oversee external partners • Act as escalation point for study-related issues • Align study goals with clinical operations and corporate objectives • Develop global tools, standards, work instructions, and SOPs • Coach and mentor junior team members and partners • Plan and manage clinical studies from feasibility through closeout • Lead trial feasibility, allocation, and site selection across regions • Manage study timelines, plans, systems, training, and Trial Master File activities • Implement risk-based quality management processes • Coordinate clinical supplies, data cleaning, and Clinical Study Report execution • Monitor compliance with protocols, SOPs, ICH/GCP, and regulations • Manage quality risks, corrective and preventative actions, audits, and inspection readiness • Select and manage vendors and approve invoice payments • Manage study budgets, forecasts, accruals, and resource needs • 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 • 8 or more years of progressive experience in clinical research within biotech, pharma or CRO industry • MS Office, Project Planning Applications, and Clinical Trial Management Systems • Bachelor’s Degree in a scientific or healthcare discipline required • Travel might be required as per business need

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness benefits