Study Start-Up Manager

🕒 3 days ago

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BeOne Medicines

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10,000+ employees

Founded 2010

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 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

• Clinical Operations leadership role with project responsibilities and accountability in the delivery of Study Start-Up (SSU), initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, SOPs, and local regulations • Ensures SSU clinical trial activities are executed to expected and specified timelines and quality standards • Monitors start-up metrics and compliance with CTMS business rules and global eTMF standards • Responsible for managing and addressing SSU performance • Actively drives best practices and process improvement to optimize efficiencies in delivery • Leads team in achievement of study, departmental, and organizational goals by providing guidance, support, and development opportunities • Demonstrates mastery of skills required to conduct SSU activities from selection through activation • Manage SSU resource allocations and conduct ongoing assessments to ensure balanced workload for quality delivery • Provide country-specific SSU expertise to project teams • Competent in communication and influencing skills to ensure timely follow-up, risk mitigation, issue resolution, and updates to teams • Manage and maintain local SSU tools and resources • Familiar with ICF GCP, relevant country regulations/guidelines, and SOPs • Facilitate SSU Forum discussions • Support in resource forecasting activities • Contribute to the development of local workflows to streamline output and deliverables • Line Management • Interview and onboard new hires; ensure ongoing training compliance • Conduct regular 1:1s to assess workload, provide guidance and feedback, develop team • Conduct mid-year and year-end performance check-ins and reviews

🎯 Requirements

• Bachelor's degree or higher in a scientific or healthcare discipline preferred • Minimum of 5 years progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, or CRO environment • Knowledge in the execution of clinical trials, understanding of ICH/GCP • Effective prioritization in the achievement of goals • Strong written and verbal communication skills • Highly organized • Diligence in follow through • Two years of management experience • Line management experience • Functional Service Provider model knowledge and/or experience • Mentoring and training team members

🏖️ Benefits

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