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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:
General Description:
Accountable for regional study delivery with appropriateinspection readinessquality, within agreed timelines and budget
Leads theregional clinical operationsteam(including oversight of external partners working on the regional level)and acts as point of escalation for resolution of issues withinthe region for the assignedstudy
Ensures alignment ofregional deliverables with overallstudy goals
Essential Functions of the job:
Regional Leadership
Leadstheregional clinical operations teameffectively,ensures effective decision making andacts as point of escalation for resolution ofissues within the region for the assignedstudy
Leads external vendors involved in study delivery on a regional level Collaborates withkeystakeholdersin the regionand provides regular updates on study progressin the regionto senior managementandGlobal Clinical Study Manageras required Represents theregionalstudy team at internal meetings andatthe cross-functional Clinical Study Team(CST)meetings Leads regional operations meetings with all regional study team members
Timelines, Planning and Execution
Leads planning and management of the assigned clinical study(ies) fromfeasibilitythrough closeout activities for region, in line with global study timelines
Generates, manages, and maintains high qualitystudy startup andrecruitmenttimelinesfor regionand tracks progress towards these
Ensures that the clinicalstudy isoperationally feasiblein the region,drivestrial feasibility, country allocationand site selection processfor assigned region in collaboration withfeasibility managers, country heads, medical affairs and any other stakeholders
Provides regional input on global study plans as required
Ensures timely availability oflocal adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holdersto ensure timely submission to regulatory authorities and ECs/IRBs
Accountable for submissions of study in countries in assigned regionin close collaboration withregionalstudy start upteamand regulatory affairs
Ensuresregional and country information in studysystems and toolsis entered and up to date
Collaborates closely with CRAs in the region to ensure proper study execution at the sites.Reviews and signs-off monitoring reports
Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained andQC’don a regular basisas per the study TMF QC plan
Provides input to Global Clinical Suppliesregarding drug inventories in regionand reviews local drug labels for region.Provides input on localregulatoryapprovaland reimbursementstatus of comparator drugs used in study for countries in region
Manages the trial data collection process for the region, drives data entry and query resolution
As required, supportsplanning and execution of the Clinical Study Report in collaboration withGlobal Clinical Study Manager and Medical Writing
Quality:
Handles escalatedissuesor problemswith the sitesin region in close collaboration with stakeholders such as country heads
Monitors study activities in region to ensure compliance withthe study protocol,SOPs, ICH/GCP and all other relevant regulations
Ensures inspection readiness for study in region at any point in time throughout the study life cycle
InformsGlobal Clinical Study Managerof any issues arisingon the study, evaluates impact and ensuressolutions are implemented
Prepares sites for quality assurance audits and inspections, drivesresponses to audit and inspection findings as appropriate
Collaborates withCST members andcolleagues to ensure cross-team, site learnings, and best practices are shared
Leads improvements and partners withCSTmembers to enhance the efficiency and the quality of the work performed on assigned studies
Contributes to development, optimizationand review of work instructions and SOPs as required
Budget and Resources
Works with the sourcing team to select and manage regional study vendors
Managesregionalstudy budgets
Works closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities
Identifies and managesregionalteam resource needs and establishes contingency plans for key resources
Monitors regional resource utilization over study lifecyleand liaises with functional managers as needed
Supervisory Responsibilities:
Provides performance feedback on team members as required
Might mentorjunior team members
Qualification Required:
Education Required: Bachelor’s Degree in a scientific or healthcare discipline required, Higher Degree preferred
Computer Skills:
MS Office, Project Planning Applications
Other Qualifications:
4or more years of progressive experience in clinical research within biotech, pharma or CRO industry
Provenexperience in clinical researchincluding relevant experience as team lead inclinicialfunctions
Experience as CRA is preferred
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 ( ).
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.