Senior Global Study Management Associate

BeOne Medicines; United States; Remote; USD 84,000 - 114,000; Full time

Benefits offered by this job

Medical Benefits

Dental Coverage

Vision Coverage

401(k) Plan

FSA/HSA

Life Insurance

Paid Time Off

Wellness Program

Job summary

BeOne Medicines Ltd. seeks a Senior Global Study Management Associate to support the Global Clinical Study Manager in delivering global studies with quality, on time, and within budget.

The role emphasizes collaboration across CSTs, vendors, and stakeholders worldwide, under the guidance of the GCSM. The position requires 3+ years in clinical research, a bachelor’s degree in a scientific field, and knowledge of regulatory guidelines.

Qualifications

• 3+ years of experience in clinical research within Biotech, Pharma or CRO
• Experience supporting global clinical studies and study management activities
• Familiarity with ICH-GCP guidelines and regulatory requirements
• Ability to collaborate with cross-functional teams and stakeholders globally

Responsibilities

• Support Global Clinical Study Manager in global study delivery and timelines
• Coordinate study logistics for CST meetings and maintain study documentation
• Assist in setting up studies in systems (eTMF, CTMS) and manage access
• Support development of study plans, reviews, and newsletters
• Assist in TMF creation and QC per TMF plan
• Contribute to budget management and vendor coordination

Skills

Cross-Functional Leadership

Clinical Study Operations

Regulatory Knowledge

Project Coordination

Education

Bachelor's degree in science/healthcare

Tools

eTMF

CTMS

SharePoint

MS Office

Job description

Senior Global Study Management Associate# Careers at BeOne## Senior Global Study Management AssociateApply: Remote (US): Full time: Posted Today: R37559BeOne 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 be made for candidates with relevant clinical operations experienceGlobal CompetenciesWhen 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 ClaritySalary Range: $83,800.00 - $113,800.00 annuallyBeOne 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].