Global Study Management Associate (gSMA)

Responsibilities

• 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 and objectives under direction of the Global Clinical Study Manager
• Supports the Global Clinical Study Manager with the organization and logistics for cross-functional Clinical Study Team (CST) meetings
• Establishes good collaboration with the Global Clinical Study Manager, Regional Clinical Trial Management Associates and other key stakeholders globally and regionally
• Knowledgeable of clinical study operations, including interpretation and implementation of regulatory and ICH-GCP guidelines
• Builds solid knowledge of global clinical trials operations under the guidance of the Global Clinical Study Manager
• Creates and maintains study-level SharePoint and CST distribution lists
• Sets up the study in the appropriate systems e.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 of various study plans
• Organizes study-specific investigator meetings under supervision of the Global Clinical Study Manager
• Might support the creation and review of site feasibility assessments required for study participation
• Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations in 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 the study TMF QC plan
• 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
• Supports the identification of operational risks and issues and works with the Global Clinical Study Manager to recommend solutions for discussion with appropriate team leadership
• Learns and shares best practices in clinical operations methodologies, systems and processes with an emphasis on quality and compliance
• Suggest improvements to enhance efficiency and the quality of the work performed on assigned projects
• 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 lifecycles

Preferred

• higher degree preferred
• Limited travel might be required

Benefits

• Non-Commercial roles are eligible to participate in the annual bonus plan
• Commercial roles are eligible to participate in an incentive compensation plan
• All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards
• Voluntarily participate in the Employee Stock Purchase Plan
• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Global oncology company developing innovative cancer treatments.
• Cambridge, Massachusetts, USA
• https://beonemedicines.com
• Late Stage
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Qualifications

• Knowledgeable of clinical study operations, including interpretation and implementation of regulatory and ICH-GCP guidelines
• Proficiency in MS Office Suite, including Excel, PowerPoint and project etc
• Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes
• 1 or more years of experience in clinical research within Biotech, Pharma or CRO industry
• Bachelor or higher degree in a scientific or healthcare discipline*
• Higher degree preferred
• Limited travel might be required

Required skills

• Clinical Study Operations, Clinical Research, Regulatory Guidelines, ICH-GCP, Clinical Trial Management Systems (CTMS), Electronic Trial Master File (eTMF), Microsoft Excel, Microsoft PowerPoint, Microsoft Project, Study Budget Management

Preferred skills

• higher degree preferred, Limited travel might be required

Experience

• 1+ years