Associate Director, Regional Clinical Study Management

About the role

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne , please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter). BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Job Description: General Description: Provides leadership, management, and/or mentorship to clinical study managers at various levels for assigned portfolio Collaborate with cross-functional teams to establish advanced planning strategies of new trials and ensure the efficient execution of clinical trials in Japan. Contributes to resourcing and capability development related to regional study management Ensures alignment of regional resources and deliverables with overall portfolio goals Inspire and lead efforts to deepen scientific knowledge within the Clinical Operations' function to drive faster, high quality clinical trials Provide expert knowledge on the execution of clinical trials, expert understanding of ICH/GCP Guidelines and other applicable regulatory requirements English - Japanese translation of study document amendments during CTN review Essential Functions of the job: Lead the development and implementation of clinical trial strategies in Japan, ensuring alignment with corporate goals and Japan objectives. Drive operational efficiency by optimizing process, leveraging digital innovations, and ensuring risk mitigation strategies are in place. Ensure that clinical trials are conducted with high quality, adhering to regulatory requirements and GCP while maintaining cost-effectiveness and speed. Build and lead a high-performing Clinical Operations team in Japan by recruiting top-tier talent, ensuring a structured onboarding process, and providing continuous professional development opportunities. Establish and improve Japan specific Work Instruction, SOPs (if any) and processes. Enhance site engagement to eliminate non or low enrolment sites and complete Japan country level patient enrolments on time. Collaborate with cross-functional teams to establish advanced planning strategies of new trials and ensure the efficient execution of clinical trials in Japan. Implementing robust processes to uphold trial quality from initiation through completion. Maintaining inspection ready for all eTMFs throughout the lifecycle of every trial. Ensuring that all clinical operations teams, investigators, and site personnel are well-trained on inspection readiness, document management, and all relevant trial materials to confidently navigate inspections when they occur. Contributes to and has accountability for overall Clinical Operations strategy and performance against key metrics Actively oversees the knowledge management process by ensuring information is captured, retained, and leveraged for future work Ensures operational processes, systems and standards are adopted and implemented consistently across trials Champions a global mindset and approach across Clinical Operations to foster increased collaboration and consistency across BeOne Ensures alignment with broader BeOne strategic initiatives and business needs and provides recommendations or ideas on how Clinical Operations' programs can generate greater value for BeOne overall Ensures Clinical Operations thinking, and activities are aligned with overall business direction and priorities Identifies opportunities and initiatives within the broader organization that can be adopted/adapted by Clinical Operations as best practice; equally recommends best practices within Clinical Operations that if more broadly applied would benefit BeOne as a whole Maintains a working knowledge of, and assures compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and SOPs Implements and revises SOPs and monitors departmental compliance Participates in formal staff performance review processes Escalates issues to BeOne Senior Management team timely Demonstrates strong initiative in activities through the clinical trials and other company initiatives Proactively identifies potential issues and seeks improvement. Takes initiative for issue resolution within and outside the Clinical Operations department. Coordinates the risk management process encomp

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