Senior Global Study Management Associate

BeOne Medicines USA; United States; On-site; USD 65,000 - 95,000; Full time

Job summary

BeOne Medicines USA is seeking an experienced clinical research professional to support global study delivery. You will align study goals with clinical operations and assist in vendor management, budgeting, and deliverable tracking.

The role requires collaboration with regional teams, knowledge of ICH-GCP, and strong MS Office and project-management skills to ensure high quality, timely execution of studies in the biotech/pharma space.

Qualifications

• 3+ years of clinical research experience in Biotech/Pharma/CRO.
• Bachelor or higher degree in scientific or healthcare discipline.
• Knowledge of clinical operations methodologies and regulatory requirements (ICH-GCP).
• Proficiency in MS Office Suite (Excel, PowerPoint) and project management tools.

Responsibilities

• Support the Global Clinical Study Manager with study planning and execution.
• Coordinate cross-functional CST meetings and document sharing.
• Assist with TMF creation and study drug forecasts.
• Monitor study deliverables and prepare management metrics.

Skills

Cross-functional collaboration

Regulatory knowledge

Leadership support

Education

Bachelor or higher degree in scientific or healthcare discipline

Tools

MS Office Suite

Excel

PowerPoint

Project

Job 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.

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
• Supports study vendor management in addition to other study management activities assigned

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
• Actively contributes to GSMA task force initiatives and cross functional projects within scope, supporting process improvement, standardization, and implementation activities as required

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 study
• Supports the development of various study plans
• May assist in the review of study-related documents as delegated by the Global Clinical Study Manager (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters)
• 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
• Might support the development of global study tools, working instructions and SOPs

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:

• Might mentor junior team members/onboarding of new hires

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
• 3 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