Global Study Management Associate

BeiGene; Oregon; Hybrid; USD 73,000 - 98,000; Full time

Benefits offered by this job

Medical, Dental, Vision insurance

401(k) and FSA/HSA benefits

Equity participation for employees

Job summary

BeiGene, Ltd. is seeking an experienced professional to support global clinical study delivery and ensure quality, timelines, and budget adherence. The role collaborates with regional teams, CST members, and other stakeholders to drive efficient study operations.

The position requires knowledge of regulatory/ICH-GCP guidelines, 1+ year in clinical research, and strong MS Office skills. Some travel may be required as part of cross-functional coordination.

Qualifications

• Knowledge of clinical operations methodologies and regulatory requirements.
• 1+ years of experience in clinical research within Biotech, Pharma or CROs.

Responsibilities

• Coordinate cross-functional CST meetings and logistics.
• Maintain study documentation in eTMF and CTMS.
• Assist with study plans, site feasibility, and data tracking.
• Support TMF creation and QC activities.
• Support study drug forecasts and supply coordination.
• Prepare study newsletters and stakeholder communications.
• Monitor study deliverables and metrics.

Skills

Cross-Functional Collaboration

Planning & Coordination

Regulatory & ICH-GCP knowledge

MS Office Proficiency

Analytical Thinking

Travel readiness

Education

Bachelor's degree in science/healthcare

Higher degree preferred

Tools

SharePoint

eTMF systems

CTMS

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

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
• Organises 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

  • 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

  Salary Range: $72,800.00 - $97,800.00 annually

  Benefits

  • The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
  • 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.

  Equal Opportunity Employer

  We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

  Reasonable Accommodation

  In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact .