Global Clinical Study Senior Manager (Senior gCSM)

BeiGene; Basel; On-site; AUD 140,000 - 190,000; Full time

Benefits offered by this job

Company shares (generous welcome grant

In-house and external learning and dev

Fantastic benefits program

Job summary

BeOne is seeking a senior Clinical Study Lead to drive global oncology studies across regions, coordinating cross-functional teams and external partners. You will ensure study timelines align with regulatory and corporate goals, manage budgets, and oversee inspection readiness.

The ideal candidate has extensive clinical research experience in biotech, pharma, or CRO environments and oncology exposure. The role requires strong leadership, planning, and communication skills to advance BeOne’s

Qualifications

• Bachelor’s Degree in a scientific or healthcare discipline required
• Advanced knowledge of clinical operations methodologies
• 6 or more years of progressive experience in clinical research within biotech, pharma or CRO
• Oncology experience preferred

Responsibilities

• Leads global cross-functional study team and external vendors
• Manages study timelines, budgets, and resources
• Ensures inspection readiness and regulatory compliance
• Oversees start-up activities, site activation, and TMF QC
• Maintains high-quality study documents and data integrity

Skills

Clinical study leadership

Cross-functional leadership

Vendor management

Regulatory inspection readiness

Oncology experience

Education

Bachelor’s Degree in a scientific or healthcare discipline

Higher Degree preferred

Tools

MS Office

Project planning apps

Clinical Trial Management Systems

Job description

About us

BeOneis 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 inBasel,Beijing, andCambridge,U.S.To learn more aboutBeOne, please visit www.beonemedicines.com and follow us onLinkedInandX(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:

• Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality
• Leads all aspects of assigned clinical study(ies)
• Leads global cross-functional study team(including oversight of external partners)and acts as point of escalation for resolution of issues within assigned study(ies)
• Ensures alignment of study goals with clinical operationsand corporategoals andobjectives
• Experience in managing global oncology studies; preferably pivotal studies and inspection management with HA

Essential Functions of the job:

Cross-Functional Leadership

• Leads the global cross-functional study team effectively, ensures effective decision making, and acts as point of escalation for resolution of study related issues
• Leads external vendorsmanagementinvolvedin study delivery
• Buildstrust and relationship with regional subject matter experts and supports the delivery of their local study objectives
• Collaborates with key stakeholders across the organization and provides regular updates on study progress to senior management asrequired
• Representsthe study team at internal meetings and leads the cross-functional Clinical Study Team (CST) meetings
• Participates and presents atvarious topicsof Clinical Study Management
• Participates in Clinical Operations Process improvement initiative

Planning andExecution

• Leads planning and management of the assigned clinical study(ies) from feasibilitythrough closeout activities
• Generates, manages,maintains, and communicates high quality study timelines and tracks progress towards these
• Ensures that the clinical studies are operationallyfeasiblealong with Global Clinical Program Lead, oversees trial feasibility, trialallocationand site selection process across all regions
• Ensurestimelyavailability of high-quality study documents to allow study submission to regulatory authoritiesand ECs/IRBs
• Provides oversight to study start up and site activation plans
• Ensuresstudy plans (egproject management plan,monitoringplan, Trial Master File plan, data monitoring plan, …) are created,updatedand distributedtimelyand implemented appropriately
• Ensures study systems and tools are set up timely, correctly and are functioning properly. Ensures study level information is updated on an ongoing basis in all systems
• ImplementsRBQM end-to-end processes on time within theallocatedstudy (e.g., periodic reviews, centralized monitoring analyses, action items)
• Ensures relevant study specific training is developed and implementedand ensures training records are well documented and filed
• Ensures Trial Master File for study is created,maintainedandQC’don a regular basisas per the study TMF QC plan
• Collaborates closely with Global Clinical Supplies to forecast study drug andtimelydelivery of supplies to sites
• Supports and as needed drives overall data cleaning timelines in close collaboration with Data Management and other stakeholders(including but not limited to regional clinical operations teams and medicator monitor)
• Ensures planning and execution of the Clinical Study Report in collaboration with Medical Writingand relevant CST members

Qualityand Risk Management

• Monitors study activities to ensure compliance withthe study protocol,SOPs,all study plans,ICH/GCP and all other relevant regulations
• Regularly reviews and manages quality-related GCO metrics to be within acceptable limits
• Ensures inspection readiness at any point in time throughout the study life cycle
• Works with cross-functional study team toidentify, interpret, and evaluate issues on the study and ensurescorrective and preventative actionsare implemented
• Ensuersenior management and other key stakeholders are informed of risks and challenges andensuresrisk mitigation plans are put in place and implemented
• Prepares team for quality assurance auditsand inspections
• CollaborateswithCST members and othercolleagues to ensure cross-team, site learnings, and best practices are shared
• Leads improvementsand partners with study team membersto enhance the efficiency and the quality of the work performed on assignedstudies
• Contributes to development, optimizationand review of work instructions and SOPs asrequired

Budget and Resources

• Works with the sourcing team to select and manage study vendors, approving invoice payment throughout the study
• Managesstudybudgets, including baseline budget evaluation, change control, study closure budget,presents studybudgetforsenior managementengagement
• Adheres to clinical study budgeting processes and provides input to finance on budget accruals and forecasts
• Identifiesand managesstudy teamresource needs andestablishescontingency plans for key resources.
• MonitorsClinical Study Teamresourceutilizationover the study life cycle
• Ensures clinical studies at a project level are executed withinendorsedtime, quality, and cost parameters

Supervisory Responsibilities:

• Provides performance feedback on team members as required

Qualification Required:

Education Required:

Bachelor’sDegree in a scientific or healthcare discipline required*, Higher Degree preferred

Computer Skills:

MS Office, Project Planning Applications, Clinical Trial Management Systems

Other Qualifications:

• Proven Project Management experience in Global Clinical Studies ( Oncology experience preferred )
• Advanced knowledge of clinical operations methodologies, in depth understanding of all aspects of clinical study processes
• Able to independently lead globalclinicalstudies(pivotal study management experience required)
• 6 or more years of progressive experience in clinical research within biotech,pharmaor CRO industry

Travel:

Travel might be required as per business need.

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.