Senior Study Start-Up Manager

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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 delivery of study start-up, initial and ongoing submissions within established timelines and quality standards • Ensure SSU clinical trial activities meet specified timelines and quality standards • Gather and monitor start-up metrics against KPIs • Drive best practices and process improvements across the SSU Team and Americas region • Lead central IRB set-up through close-out • Serve as key contact for SSU onboarding and process improvement in the Americas • Conduct SSU activities from site identification through activation • Provide country-specific SSU expertise to project teams • Provide SSU Lead backup support for studies as needed • Drive timely follow-up, issue resolution, and report updates • Manage SSU resources, including the SSU Toolbox • Engage sites during feasibility, execute CDAs, and collect information for site identification and selection • Liaise with CRAs, FMDs, CSMs, and other internal stakeholders • Recommend potential first sites to achieve FPI • Drive kick-off and completion of tasks from site selection through activation • Use site partnership data to improve start-up efficiency and reduce cycle times • Prepare, negotiate, and manage documents and submissions from start-up through close-out • Prepare and submit documents to the central IRB • Facilitate SSU Forum discussions • Support development of local workflows • Manage resource allocations and participate in resource forecasting • Improve SSU infrastructure in the Americas • Interview and onboard BeOne hires • Ensure training compliance • Conduct 1:1s, provide feedback, track goals, and develop team members • Conduct mid-year and year-end performance check-ins and reviews • Onboard FSP new hires and provide guidance, mentoring, and development • Participate in meetings with FSP leadership and line managers

🎯 Requirements

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred • Minimum of 7+ years of progressive experience in clinical research and clinical operations • Experience preferably within the biotech, pharmaceutical sector, or CRO environment • Knowledge of clinical trial execution • Understanding of ICH/GCP • Knowledge of relevant country regulations, guidelines, and SOPs • Proficiency in Microsoft Office: Outlook, Word, Excel, PowerPoint, and Teams • Effective prioritization of tasks • Strong written and verbal communication skills • Highly organized • Diligence in follow-through • Risk mitigation skills • Line management experience • Functional Service Provider model knowledge and/or experience • Mentoring and training team members • Ability to travel up to 10%

🏖️ Benefits

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