Senior Study Start-Up Manager

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $136.4k - $181.4k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 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

• Deliver study start-up, initial and ongoing submissions within established timelines and quality standards • Ensure study start-up clinical trial activities comply with ICH/GCP, BeOne SOPs, and local regulations • Gather and monitor start-up metrics against KPIs • Drive best practices and process improvements within the Study Start-Up team and Americas region • Lead central IRB set-up through close-out • Serve as key contact for Study Start-Up onboarding and process improvement in the Americas • Provide Study Start-Up expertise to project teams • Provide backup support as Study Start-Up Lead for assigned studies • Manage and maintain Study Start-Up resources, including the Americas SSU Toolbox • Engage sites during feasibility, execute CDAs, collect site-identification information, and liaise with CRAs, FMDs, and CSMs • Provide strategic recommendations on 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, manage, and submit ICF/submission documents • Prepare and submit documents to central IRB • Facilitate Study Start-Up Forum discussions • Support development of local workflows • Manage resource allocations and participate in resource forecasting • Contribute to Study Start-Up infrastructure improvements across the U.S., Canada, and Latin America • Interview and onboard line-management new hires and ensure training compliance • Conduct regular 1:1s, performance check-ins, reviews, feedback, and goal tracking • Onboard FSP new hires, mentor and develop team members, and coordinate with FSP leadership and line managers • Perform additional tasks as assigned to achieve organizational goals

🎯 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, preferably within the biotech, pharmaceutical sector, or CRO environment • Mastery of skills required to conduct study start-up activities from site identification through activation • Country-specific study start-up expertise • Familiarity with ICH/GCP, relevant country regulations/guidelines, and SOPs • Knowledge in the execution of clinical trials • Proficiency in Microsoft Office: Outlook, Word, Excel, PowerPoint, Teams • Effective prioritization of tasks • Strong written and verbal communication skills • Highly organized • Diligence in follow through • Skilled in risk mitigation • Line management experience • Functional Service Provider model knowledge and/or experience • Experience mentoring and training team members

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility 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 program • Up to 10% travel