Senior Global Clinical Study Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $136.4k - $181.4k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 end-to-end global operational delivery of one or more clinical studies from study start-up through close-out • Lead global clinical operations teams, including regional external partners • Serve as the primary global operational owner and single point of accountability for study execution • Align cross-functional stakeholders and drive global study strategy execution • Act as point of escalation for regional issues and resolutions • Ensure alignment of global deliverables with study goals • Oversee study start-up strategy, enrollment acceleration plans, site activation timelines, data flow and query resolution • Provide oversight and direction to regional clinical study managers • Lead planning and management from feasibility through closeout • Manage study start-up and recruitment timelines and track progress • Drive trial feasibility, country allocation and site selection for the assigned region • Ensure timely availability and submission of global study documents to regulatory authorities and ECs/IRBs • Maintain accurate study information in systems and tools • Collaborate with CRAs to ensure site execution and review/sign off monitoring reports • Ensure country- and site-level Trial Master Files are created, maintained and quality-controlled • Provide input on drug inventories, local drug labels, regulatory approval and reimbursement status of comparator drugs • Manage regional trial data collection, data entry and query resolution • Support Clinical Study Report planning and execution • Monitor compliance with protocols, SOPs, ICH/GCP and relevant regulations • Ensure inspection readiness and prepare sites for audits and inspections • Manage audit and inspection finding responses • Lead process improvements and development, optimization and review of work instructions and SOPs • Plan, track and forecast global study budgets • Allocate resources across regions and manage cost versus performance trade-offs • Select and manage study vendors with the sourcing team • Manage regional study budgets and investigator fees, site payments and patient travel reimbursement activities • Identify resource needs and establish contingency plans • Represent study leadership in cross-functional reviews • Communicate study status, risks, trade-offs and mitigation plans • Mentor junior team members and support onboarding

🎯 Requirements

• Over 5 years’ project management in clinical trials within the biotech, pharmaceutical sector, CRO industry or relevant field • Proven experience in clinical research including relevant experience as team lead in clinical functions • Bachelor’s Degree in a scientific or healthcare discipline required • Higher Degree preferred • Proficiency with MS Office and Project Planning Applications • Knowledge of clinical study execution from start-up through close-out • Knowledge of study protocols, SOPs, ICH/GCP and relevant regulations • Ability to manage global study timelines, quality, budget, resources and vendors • Travel might be required as per business need

🏖️ Benefits

• Annual bonus plan for non-commercial roles • Incentive compensation plan for 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 • Travel as required by business need