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.
To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

BeOne Medicines

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clinical-operations

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.

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.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

• Enhance Global Clinical Operations productivity and reduce clinical trial inefficiencies
• Detail enhancements for CTMS and other digital solutions used across clinical trial planning, start-up, management, and close-out
• Engage clinical stakeholders across geographies and functions to define CTMS enhancement needs
• Elicit and align business, regional, and process requirements
• Prioritize demand, manage competing interests, communicate priorities, and translate them into development plans
• Draft and finalize business requirements for prioritized enhancements
• Coordinate with Development and IT teams on user stories, sprint planning, sprint testing, SDLC testing, and UAT
• Ensure digital applications align with GCO processes and create process flows where needed
• Support near-term and long-term CTMS and digital solution roadmaps
• Define value propositions and track business outcome measures for digital investments
• Represent GCO business interests on implementation teams
• Review proposed designs for fit, value, and business needs
• Curate the demand backlog and maintain user stories and priorities
• Manage the network of end-user champions and facilitate two-way communication
• Set up and maintain a SharePoint website for end-user and champion communications
• Analyze technology and industry trends to identify innovative, cost-effective solutions
• Implement the GCO technology roadmap
• Monitor, evaluate, optimize, troubleshoot, and resolve technology solution issues
• Manage project progress, timelines, accountabilities, risks, and costs
• Partner with Development Data Science, QA, IT, Clinical Operations, Data Management, and Supply Chain
• Develop solution requirements and standards
• Identify manual workflows and pain points and develop technological solutions
• Ensure business value realization and deliver change tactics including communications, training, user communities, and adoption drives
• Prioritize system usability, user satisfaction, and reduced user burden
• Work as an individual contributor and oversee consultants or analysts on a matrixed team as needed

Senior Manager, Digital Clinical Operations

Senior Manager optimizing CTMS and digital solutions for BeOne’s global clinical operations. Improving clinical trial efficiency, compliance, and technology value realization.

general

• Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne’s SOPs, and local regulations
• Contribute to discussions during the feasibility stage of site selection
• Drive kick-off and completion of tasks from selection through activation, including providing timeline input for site activations
• Leverage and build upon existing site partnership data to execute start-up efficiently and reduce cycle times
• Manage document preparation, negotiation, and submission to achieve submission targets from start-up through close-out
• Prepare and submit documents to central IRB to ensure timely reviews
• Ensure collection and review of essential documents
• Complete SSU data entry in CTMS
• Complete timely and quality eTMF filing
• Support development of local workflows to streamline output and deliverables
• Contribute to ongoing improvement of SSU infrastructure in North America
• Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals

Senior Study Start-Up Specialist

Senior Study Start-Up Specialist managing clinical trial submissions, site activation, and essential documents for BeOne’s oncology-focused operations in Canada.

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. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

BeOne Medicines

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Senior Manager, Digital Clinical Operations

BeOne Medicines

Senior Study Start-Up Specialist

BeOne Medicines