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:
General Description:
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Accountable for regional study delivery with appropriateinspection readinessquality, within agreed timelines and budget
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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
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Ensures alignment ofregional deliverables with overallstudy goals
Essential Functions of the job:
Regional Leadership
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Leadstheregional clinical operations teameffectively,ensures effective decision making andacts as point of escalation for resolution ofissues within the region for the assignedstudy
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Leads external vendors involved in study delivery on a regional level
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Collaborates withkeystakeholdersin the regionand provides regular updates on study progressin the regionto senior managementandGlobal Clinical Study Manageras required
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Represents theregionalstudy team at internal meetings andatthe cross-functional Clinical Study Team(CST)meetings
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Leads regional operations meetings with all regional study team members
Timelines, Planning and Execution
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Leads planning and management of the assigned clinical study(ies) fromfeasibilitythrough closeout activities for region, in line with global study timelines
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Generates, manages, and maintains high qualitystudy startup andrecruitmenttimelinesfor regionand tracks progress towards these
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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
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Provides regional input on global study plans as required
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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
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Accountable for submissions of study in countries in assigned regionin close collaboration withregionalstudy start upteamand regulatory affairs
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Ensuresregional and country information in studysystems and toolsis entered and up to date
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Collaborates closely with CRAs in the region to ensure proper study execution at the sites.Reviews and signs-off monitoring reports
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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
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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
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Manages the trial data collection process for the region, drives data entry and query resolution
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As required, supportsplanning and executi