Global Clinical Study Manager

BeOne Medicines

. Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality .

Posted 10/6/2026full-timeRemote • United StatesMid-LevelSenior💰 $118,600 - $158,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing global clinical studies, ensuring alignment with corporate objectives, and maintaining compliance with regulatory standards. Proficient in project management, vendor oversight, and cross-functional team leadership within the biotech or pharmaceutical industry.

Highest-signal resume keywords

Project Management ExperienceClinical Trial Management SystemsOncology ExperienceClinical Operations MethodologiesRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ProcessesStudy Budget ManagementRisk-Based Quality ManagementData Cleaning TimelinesTrial Master File ManagementStudy Timeline ManagementSite SelectionFeasibility PlanningCorrective and Preventive ActionsInspection Readiness

Soft Skills

LeadershipCommunicationCollaborationProblem-SolvingTeam Management

Tools & Technologies

MS OfficeProject Planning ApplicationsClinical Trial Management Systems

Industry Keywords

BiotechPharmaCROICH/GCPSOPsClinical ResearchStudy Vendor ManagementStudy Activation PlansStudy Progress UpdatesQuality Assurance Audits

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Accountable for global study delivery within agreed timelines and budget with appropriate inspection readiness quality
Lead all aspects of assigned clinical studies
Lead global cross-functional study teams, including oversight of external partners, and act as point of escalation for study issues
Ensure study goals align with clinical operations and corporate objectives
Manage external vendors and collaborate with regional subject matter experts
Provide regular study progress updates to senior management
Represent the study team at internal meetings and lead Clinical Study Team meetings
Lead planning and management from feasibility through closeout
Create, manage, maintain, and communicate study timelines
Oversee trial feasibility, allocation, and site selection across regions
Ensure timely availability of study documents for regulatory and ethics submissions
Oversee study start-up and site activation plans
Ensure study plans, systems, and tools are created, implemented, and maintained
Implement risk-based quality management processes and centralized monitoring analyses
Develop and implement study-specific training and maintain training records
Create, maintain, and quality-check the Trial Master File
Forecast study drug and coordinate timely delivery of supplies to sites
Support data cleaning timelines with Data Management and other stakeholders
Plan and execute the Clinical Study Report with Medical Writing and study team members
Monitor compliance with protocol, SOPs, study plans, ICH/GCP, and applicable regulations
Review and manage quality-related metrics and maintain inspection readiness
Identify study issues and ensure corrective and preventive actions are implemented
Communicate risks and challenges to senior management and implement mitigation plans
Prepare the team for quality assurance audits and inspections
Share cross-team, site learnings, and best practices
Lead process improvements and contribute to work instructions and SOPs
Select and manage study vendors and approve invoice payments
Manage study budgets, change control, closure budgets, accruals, and forecasts
Identify study team resource needs and monitor resource utilization
Ensure studies are executed within approved time, quality, and cost parameters

Requirements

What you’ll need

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
Ability to independently lead global clinical studies
6 or more years of progressive experience in clinical research within biotech, pharma, or CRO industry
MS Office proficiency
Project planning applications proficiency
Clinical Trial Management Systems proficiency
Bachelor's Degree in a scientific or healthcare discipline required; higher degree preferred
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 eligibility
Voluntary Employee Stock Purchase Plan participation
Medical insurance
Dental insurance
Vision insurance
401(k)
FSA/HSA
Life insurance
Paid Time Off
Wellness benefits
Reasonable accommodation in the job application process