Global Study Management Associate; gSMA)

Position: Global Study Management Associate (gSMA)

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.
General Description:
• Supports the Global Clinical Study Manager in global study delivery and ensures that delegated components of clinical studies are executed to expected and specified quality standards, within timelines and budget
• Supports the alignment of study goals with clinical operations goals andobjectivesunder direction of the Global Clinical Study Manager
Essential Functions of the Job:
Cross-Functional Leadership Support & Collaboration
• Supports the Global Clinical Study Manager with the organization andlogisticsfor cross-functional

Clinical Study Team (CST) meetings
• Establishes good collaboration with the Global Clinical Study Manager, Regional Clinical Trial Management Associate sand other key stakeholders globally and regionally
• Knowledgeable of clinicalstudyoperations, including interpretation and implementationofregulatory and ICH-GCPguidelines
• Builds solid knowledge of global clinical trials operations under the guidance of the Global Clinical Study Manager
Planning and Execution
• Creates andmaintainsstudy-level

SharePoint andCSTdistribution lists
• Sets up the study in the appropriate systemse.g.eTMF,CTMS etc and makes sure study-level information is kept up to date
• Ensures system access is granted and managed appropriately across the study life cycle, supports user account management for systems used in the study
• Supports the development ofvariousstudy plans
• Organizes study-specific investigator meetings under supervision of the Global Clinical Study Manager
• Might support the creation and review ofsite feasibility assessmentsrequiredfor study participation
• Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, dataflowand protocol deviationsin relevant systems in collaboration with Regional Clinical Trial Management Associates
• Prepares metrics and updates to key deliverables for management as per information available in relevant systems
• Supports the preparation of a study newsletter and other correspondence related to the study conduct (e.g.frequently asked questions, lessons learned) in collaboration with the study team
• Supports the TMF specialist with study-level TMF creation and, as required,maintains the study-level TMF, including regular review and QC of TMF documents as per thestudy TMF QCplan
• Supports the Global Clinical Study Manager with study drug forecasts and overall study drug supply activities in collaboration with Global Clinical Supplies
• Supports the overall data cleaning activities and contributes to the follow-up of outstanding information
• Supports the Global Clinical Study Manager with planning and execution of the Clinical Study Report
Quality
• Supports the identification of operational risksand issuesand works with the Global Clinical Study Managerto recommend solutions for discussion with appropriate team leadership
• Learns and shares best practices in clinical operations methodologies,system sand processes with an emphasis on quality and compliance
• Suggest improvements to enhanceefficiencyand the quality of the work performed on assigned projects
Budget
• Supports selection and set-up of vendors for global outsourced activities
• Supports study budget management activities with responsibility for PO setup and payment invoice tracking across all study life cycles.
Supervisory Responsibilities:

N/A
Computer

Skills:

Proficiency in MS Office Suite, including Excel, PowerPoint and project etc.
Other

Qualifications:
• Knowledge of clinical operations…