Global Study Management Associate

BeOne Medicines USA; United States; On-site; USD 73,000 - 98,000; Full time

Job summary

BeOne Medicines USA is seeking a candidate to support Global Clinical Study Manager in coordinating cross-functional CST meetings and ensuring smooth study operations. The role involves maintaining system access, study plans, and TMF quality control across the study lifecycle.

The ideal candidate has 1+ year in clinical research, a science/healthcare degree, and strong MS Office skills. Travel may be limited and a higher degree is a plus.

Qualifications

• Knowledge of clinical operations methodologies and study processes.
• 1+ years of experience in clinical research within Biotech, Pharma or CRO.
• Bachelor or higher degree in a scientific or healthcare discipline; higher degree preferred.

Responsibilities

• Support Global Clinical Study Manager with study logistics and CST meetings.
• Maintain study documentation in eTMF/CTMS and manage system access.
• Assist with study plans, budgets, and vendor-related activities.
• Prepare study newsletters and other study communications.
• Contribute to TMF creation and quality control; support drug forecasting.

Skills

Clinical operations knowledge

Regulatory understanding

Cross-functional collaboration

Education

Bachelor's degree in science/healthcare

Tools

MS Office Suite

Job description

General Description

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.

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.

Supervisory Responsibilities

N/A

Computer Skills

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

Other Qualifications

• 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

Travel

Limited travel might be required

Education Required

Bachelor or higher degree in a scientific or healthcare discipline*, higher degree preferred.

*exceptions might be made for candidates with relevant clinical operations experience

Global Competencies

When 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 Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $72,800.00 - $97,800.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several