Global Study Management Associate (gSMA)

BeOne Medicines; United States; On-site; USD 72,800 - 97,800; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k)

Job summary

BeOne Medicines is seeking aClinical Study Support professional to assist the Global Clinical Study Manager in delivering global studies with quality and on-time performance. This role focuses on coordinating cross-functional teams, managing study systems (eTMF, CTMS), and preparing communications for the CST.

The ideal candidate has a science/healthcare background and at least one year of clinical research experience, with strong MS Office skills and knowledge of regulatory guidelines.

Qualifications

• Bachelor or higher degree in a scientific or healthcare discipline is required, higher degree preferred.
• 1+ years of experience in clinical research within Biotech, Pharma or CRO industry.
• Knowledge of clinical operations methodologies and regulatory guidelines (ICH-GCP).

Responsibilities

• Supports the Global Clinical Study Manager in global study delivery and ensures quality, timelines, and budget.
• Supports study planning, site coordination, meetings and cross-functional collaboration.
• Maintains study systems (eTMF/CTMS) and distributes study information to CST.
• Prepares study newsletters and manages TMF review and QC activities.
• Assists with study drug forecasts and overall study drug supply activities.
• Supports data cleaning and follow-up of outstanding information.

Skills

Clinical operations knowledge

MS Office proficiency

Collaboration skills

Education

Bachelor or higher in science/healthcare

Tools

MS Office (Excel/PowerPoint)

eTMF

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
• 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 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].