Global Study Management Associate

BeOne Medicines; San Mateo (CA); On-site; USD 90,000 - 150,000; Full time

Job summary

BeOne Medicines Ltd. in San Mateo, CA seeks a Clinical Operations support professional to help manage global study delivery and ensure quality within timelines and budgets.

You will assist in coordinating CST meetings, setting up studies in eTMF/CTMS, and maintaining study information. The role involves collaboration with regional teams and ensuring regulatory compliance throughout the study lifecycle.

Qualifications

• 1+ years of experience in clinical research within Biotech, Pharma or CRO industry.
• Knowledge of clinical operations methodologies and regulatory guidelines (ICH-GCP).
• Ability to organize cross-functional CST meetings and coordinate study activities.
• Proficiency with study setup in systems (eTMF, CTMS) and data management.

Responsibilities

• Coordinate cross-functional CST meetings and collaborate with stakeholders globally.
• Support study setup in eTMF, CTMS and related systems; ensure up-to-date study information.
• Manage study access and user accounts across the study lifecycle.
• Assist in developing and tracking study plans and deliverables.
• Support TMF creation, maintenance, and QC per plan.
• Assist with study drug forecasts and global supply activities.
• Prepare metrics and newsletters; communicate study status to team.
• Support data cleaning and follow-up of outstanding information.

Skills

Cross-functional leadership

Planning

Quality management

Budget management

Vendor management

MS Office proficiency

Travel willingness

Clinical operations knowledge

Education

Bachelor or higher in science/healthcare

Higher degree preferred

Tools

eTMF

CTMS

SharePoint

Job description

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.

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

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.