Global Study Management Associate (gSMA)

BeiGene, Ltd.; United States; Remote; USD 72,800 - 97,800; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

FSA/HSA

Life insurance

Paid time off

Wellness program

Job summary

BeOne Medicines Ltd. is seeking a Clinical Operations professional to support the Global Clinical Study Manager in delivering global studies. You will organize CST meetings, ensure systems like eTMF and CTMS are up to date, and assist in planning and measurement of study deliverables.

Strong knowledge of clinical operations, ICH-GCP guidelines, and collaboration with regional teams is required. The role involves limited travel and a robust benefits package, with real opportunity to contribute to

Qualifications

• Bachelor or higher in a scientific or healthcare discipline
• Experience in clinical operations within biotech, pharma or CRO
• Knowledge of regulatory and ICH-GCP guidelines

Responsibilities

• Support Global Clinical Study Manager with CST meetings and collaboration
• Set up the study in systems (eTMF, CTMS) and maintain study information
• Develop and monitor study plans, deliverables, and timelines
• Assist TMF creation and QC per the TMF plan

Skills

MS Office

Excel

PowerPoint

Project coordination

Communication

Education

Bachelor or higher degree in a scientific or healthcare discipline

Tools

MS Office Suite

CTMS

eTMF

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 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

• 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 factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. 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.

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. 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 [e-mail].

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram. For more information, please visit the link to explore job opportunities in China Mainland. China Mainland Job Posting At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things. Patients First Driving Excellence Bold Ingenuity Collaborative Spirit