Global Clinical Study Manager

BeOne Medicines

. Accountable for global study delivery within agreed timelines, budget, quality, and inspection-readiness requirements .

Posted 11/11/2026full-timeRemote • United StatesMid-LevelSenior💰 $118,600 - $158,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing global clinical studies, ensuring compliance with regulatory standards, and leading cross-functional teams to achieve study objectives. Proficient in project management, clinical operations methodologies, and maintaining inspection readiness throughout the study lifecycle.

Highest-signal resume keywords

Project Management ExperienceClinical Operations MethodologiesGlobal Clinical Study LeadershipOncology ExperienceClinical Trial Management Systems

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Study ProcessesStudy Planning and ManagementRisk-Based Quality ManagementTrial Master File MaintenanceBudget ManagementData Cleaning TimelinesStudy Vendor ManagementRegulatory ComplianceStudy Timeline GenerationSite Activation Plans

Soft Skills

Stakeholder CollaborationTeam LeadershipCommunication SkillsProblem-SolvingRelationship Building

Tools & Technologies

MS OfficeProject Planning ApplicationsClinical Trial Management Systems

Industry Keywords

Clinical ResearchBiotechPharmaCROInspection ReadinessICH/GCPSOP DevelopmentStudy FeasibilityChange ControlQuality Assurance Audits

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Accountable for global study delivery within agreed timelines, budget, quality, and inspection-readiness requirements
Lead all aspects of assigned clinical studies
Lead global cross-functional study teams and oversee external partners
Act as escalation point for study-related issues
Align study goals with clinical operations and corporate objectives
Manage external vendors and study delivery partners
Build relationships with regional subject matter experts and support local study objectives
Collaborate with stakeholders and provide study-progress updates to senior management
Represent study teams at internal meetings and lead Clinical Study Team meetings
Lead study planning and management from feasibility through closeout
Generate, maintain, and communicate study timelines and track progress
Oversee trial feasibility, allocation, and site selection across regions
Ensure study documents support regulatory authority and EC/IRB submissions
Oversee study start-up and site activation plans
Create, update, distribute, and implement study plans
Ensure study systems and tools are set up and functioning properly
Implement risk-based quality management processes
Develop and implement study-specific training and maintain training records
Create, maintain, and regularly QC the Trial Master File
Forecast study drug and coordinate timely supply delivery to sites
Support data cleaning timelines with Data Management and other stakeholders
Plan and execute Clinical Study Reports with Medical Writing and study team members
Monitor compliance with protocols, SOPs, study plans, ICH/GCP, and applicable regulations
Review and manage quality-related metrics
Maintain inspection readiness throughout the study lifecycle
Identify study issues and ensure corrective and preventive actions are implemented
Communicate risks and challenges and implement mitigation plans
Prepare teams for quality assurance audits and inspections
Share cross-team, site learnings, and best practices
Lead improvements to enhance study efficiency and quality
Contribute to work instructions and SOP development and review
Select and manage study vendors and approve invoice payments
Manage study budgets, change control, closure budgets, accruals, and forecasts
Identify resource needs and establish contingency plans
Monitor Clinical Study Team resource utilization
Provide performance feedback on team members as required

Requirements

What you’ll need

Bachelor’s Degree in a scientific or healthcare discipline required; higher degree preferred
Exceptions might be made for candidates with relevant clinical operations experience
Proven project management experience in global clinical studies; oncology experience preferred
Advanced knowledge of clinical operations methodologies
In-depth understanding of all aspects of clinical study processes
Able to independently lead global clinical studies
Pivotal study management experience required
5+ years of progressive experience in clinical research within biotech, pharma or CRO industry
Proficiency with MS Office, project planning applications, and clinical trial management systems
Travel might be required as per business need

Benefits

Comp & perks

Annual bonus plan eligibility for non-commercial roles
Incentive compensation plan eligibility for commercial roles
Discretionary equity awards
Voluntary participation in the Employee Stock Purchase Plan
Medical insurance
Dental insurance
Vision insurance
401(k)
FSA/HSA
Life insurance
Paid Time Off
Wellness program
Reasonable accommodation in the job application process