Regional Clinical Study Manager

About us

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 or relevant field

• Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required

• Management experience of CROs and other Vendors preferred

• Therapeutic or medical knowledge preferred

• Experience developing trial plans including project plan, site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required. 

• Exhibits a strong understanding of methodologies and approaches

• Strong written and verbal communication skills

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme

• Company shares (generous welcome grant!)

• In-house and external learning and development opportunities

• Fantastic benefits program and keep improving!

• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.

• Join us and Make momentum in your career!

BeOne Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.