Senior Global Clinical Study Manager

🔥 17 minutes ago

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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 • Leads all aspects of assigned clinical study(ies) • Leads global cross-functional study team (including oversight of external partners) and acts as point of escalation for resolution of issues within assigned study(ies) • Ensures alignment of study goals with clinical operations and corporate goals and objectives • Contributes to development of global tools and standards, leads the development of work instructions and SOPs as required • Ensures timely availability of high-quality study documents to allow study submission to regulatory authorities and ECs/IRBs • Monitors study activities to ensure compliance with the study protocol, SOPs, all study plans, ICH/GCP and all other relevant regulations • Works with cross-functional study team to identify, interpret, and evaluate issues on the study and ensures corrective and preventative actions are implemented

🎯 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 • Able to independently lead global clinical studies • 7+ or more years of progressive experience in clinical research within biotech, pharma or CRO industry • Bachelor's Degree in a scientific or healthcare discipline required*, Higher Degree preferred *exceptions might be made for candidates with relevant clinical operations experience.

🏖️ Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness