Regional Clinical Study Manager

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: Description for focusing on Japan: Supports Senior Director to build Japan organization and required process such as Local SOP and WI. Conducts Country level feasibility. Supports country activity for new studies until regional/ country CSM is identified. Supports Senior Director for vendor management for FSP partner/ Full Outsourcing in Japan. Oversees FSP studies performance in Japan. Improves FSP's study execution process in Japan in collaboration with FSP partner. Maintains FSP Quality Metrics. Takes onboarding actions for FSP new hires. Oversees and support regional CSM for Japan specific regulations and tasks. Takes trial management responsibility if required. Conducts Site Motivation visits and Study Oversight Visits for all studies in Japan. Prepares and supports PMDA inspection Other tasks, if needed. Purpose of Job in JAPAC: Leads all aspects of assigned clinical trial(s) and demonstrates a high level of knowledge of clinical operations' methodologies, organizational, project management and leadership capabilities Leads matrix, multi-disciplinary, cross-functional study execution teams (CST) from start-up through to closeout to ensure both internal and external deliverables are on time and on budget working under the guidance and direction of the Clinical Program Lead. Ensures that clinical trials are operationally feasible while understanding the external landscape, including a focus on KOL activity Works to ensure adherence to a standardized approach to clinical trial management Ensures successful clinical trial planning, execution and delivery - within specified quality, time and cost parameters Ensures alignment of clinical project goals with Clinical Operations program objectives Major Responsibilities in JAPAC: Participates in clinical trial scenario planning (estimates timeline and cost, request internal resource) Works with Strategic resourcing team to select study vendors Oversees study vendors to ensure quality and delivery Oversees the development of and adherence to clinical trial project timelines Ensures senior Clinical Operation staff, Development Core Team (DCT), and line function heads are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks Coordinates the relevant and timely exchange of information / materials (e.g., subject enrollment, site selection/feasibility, and data collection) with other BeiGene functions (primarily those represented on CST) to support clinical trials delivery within the drug development process Ensures study plans (including but not limited to project plan, communication plan, issue escalation plan, clinical monitoring plan, medical monitoring plan, drug safety monitoring plan, data monitoring plan, Trial Master File plan and etc) are created, updated and distributed timely Coordinates with Clinical Supply Chain regarding drug forecasting and supply of drug products to sites Ensures site monitoring reports are accurate and reviewed on a regular basis Closely monitors Case Report Form (CRF) data entry and source document verification (SDV) status Ensures that Trial Master File (TMF) for assigned clinical trial(s) is created, maintained, QC checked and complete on a timely basis Reviews trial scope, budget and change orders. Adheres to clinical trial budgeting process and provides input to finance on budget accruals and forecasts Adheres to and contributes to the development and review of Clinical Operations Work Instructions and SOPs, if required Supervisory Responsibilities: CSM to oversee and mentor new CSM, if required Qualification Required: Education Required: Bachelors degree or higher in a scientific or healthcare discipline preferred Fluent in English Excellent organizational skills and ability to prioritize and multi-task 5 years or above of progressive experience in clinical research within the biotech, pharmaceutical sector, CRO industry