Senior Regional Clinical Study Manager

Join to apply for the Senior Regional Clinical Study Manager role at BeOne MedicinesJoin to apply for the Senior Regional Clinical Study Manager role at BeOne MedicinesGet AI-powered advice on this job and more exclusive features.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.PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATIONLanguage Requirement: Portuguese and English required.
Spanish preferred.Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, OncologyGeneral DescriptionAccountable for regional study delivery with appropriate inspection readiness quality within agreed timelines and budgetActs as regional lead for multiple studies across an indication or across a program as requiredLeads the regional clinical operations team (including external partners working on a regional level) and acts as thepoint of escalation for theresolution of issues within the region for the assigned studyEnsures alignment of regional deliverables with overall study goalsContributes to the development of regional tools and leads to the development of work instructions and SOPs as requiredEssential FunctionsRegional Leadership:Leads the regional clinical operations team effectively, ensures effective decision-making making and acts as a point of escalation for theresolution of issues within the region for the assigned studyLeads external vendors involved in study delivery on a regional levelCollaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as requiredRepresents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetingsLeads regional operations meetings with all regional study team membersDisplays therapeutic area knowledge and expertiseTimelines, Planning And ExecutionLeads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for theregion, in line with global study timelinesGenerates, manages, and maintains high-quality study start-up and recruitment timelines for region and tracks progress towards theseEnsures that clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholdersProvides regional input on global study plans as requiredEnsures timely availability of local adaptations of global study documents, such as informed consent forms, in close collaboration with other key stakeholders to ensure timely submission to regulatory authorities and ECs/IRBsAccountable for submissions of study in countries in assigned regions in close collaboration with regional study start-up team and regulatory affairsEnsures regional and country information in study systems and tools is entered and up to dateCollaborates closely with CRAs in the region to ensure proper study execution at the sites.
Reviews and signs-off monitoring reportsResponsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC'd regularly as per the study TMF QC planProvides input to Global Clinical Supplies regarding drug inventories in region and reviews local drug labels for region.
Provides input on local regulatory approval and reimbursement status of comparator drugs used in study for countries in theregionManages the trial data collection process for the region, drives data entry and query resolutionAs required, supports planning and execution of the Clinical Study Report in collaboration with theGlobal Clinical Study Manager and Medical WritingQualityHandles escalated issues or problems with the sites in theregion in close collaboration with stakeholders such as country headsMonitors study activities in theregion to ensure compliance with thestudy protocol, SOPs, ICH/GCP and all other relevant regulationsEnsures inspection readiness for study in theregion at any point in time throughout the study life cycleInforms Global Clinical Study Manager of any issues arising from the study, evaluates theimpact and ensures solutions are implementedPrepares sites for quality assurance audits and inspections, drives responses to audit and inspection findings as appropriateCollaborates with CST members and other colleagues to ensure cross-team, site learnings, and best practices are sharedLeads improvements and partners with CST members to enhance efficiency and the quality of the work performed on assigned studiesLeads the development, optimization, and review of work instructions and SOPs as requiredBudget And ResourcesWorks with the sourcing team to select and manage regional study vendorsManages regional study budgetsWorks closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activitiesIdentifies and manages regional team resource needs and establishes contingency plans for key resourcesMonitors regional resource utilization over thestudy life cycle and liaises with functional managers as neededMinimum Requirements – Education And ExperienceBachelor's degree or higher in a scientific or healthcare discipline preferred with a minimum of 7 or more years of progressive experience in clinical research within biotech, pharma or CRO industryA minimum of 1-3 years of relevant clinical operations experience.Other ExperienceProven experience in clinical research including relevant experience as team lead in clinical functionsExperience as CRA is preferredSupervisory ResponsibilitiesProvides performance feedback on team members as requiredMentors junior team members and might take online management responsibilities as requiredAs Required, Line Management ResponsibilitiesActs as line manager for study start-up and trial monitoring staff (incl SSUS, CRAs).
Responsibilities include planning, assigning, and directing work, assessing performance and guiding professional development of direct reports.Participate in selection for hiring and allocation of resources to clinical research project.Conducts performance appraisals and supports the establishment of development plans for direct reports, including providing feedback.Travel: Travel might be required as per business needComputer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.Global CompetenciesWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClarityWe are proud to be an equal opportunity employer.
BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.
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