Global Study Management Associate (gSMA)

BeiGene

8d

About The Position

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 and objectives under 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 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 Planning and Execution 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 Quality 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 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 lifecycles.

Requirements

• 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

Responsibilities

• 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.

Benefits

• All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.
• The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed