Senior Study Start-Up Manager

🔥 6 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 • Conduct study start-up activities from site identification through activation • Provide country-specific study start-up expertise to project teams • Provide back-up support for study start-up leads • Engage sites during feasibility, execute CDAs, and collect information supporting 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 • Leverage site partnership data to reduce start-up cycle times • Prepare, negotiate, manage, and submit documents from start-up through close-out • Prepare and submit documents to central IRB for timely reviews • Facilitate study start-up forum discussions • Develop local workflows to streamline deliverables • Manage resource allocations and participate in resource forecasting • Improve study start-up infrastructure across the Americas • Interview and onboard line-management and FSP new hires • Ensure ongoing training compliance • Conduct regular 1:1s, provide feedback, track goals, mentor, and develop team members • Conduct mid-year and year-end performance check-ins and reviews • 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, 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 • Knowledge of ICH/GCP, relevant country regulations/guidelines, and SOPs • Knowledge in the execution of clinical trials • 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 • Proficiency in Microsoft Office: Outlook, Word, Excel, PowerPoint, and Teams • Ability to manage and maintain study start-up resources • Up to 10% travel

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards opportunity • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness benefits • Up to 10% travel