Regional Clinical Study Manager

BeOne Medicines

. Accountable for regional study delivery with inspection readiness quality, within agreed timelines and budget .

Posted 10/2/2026full-timeRemote • United StatesMid-LevelSenior💰 $136,400 - $181,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing regional clinical studies, ensuring compliance with protocols, SOPs, and ICH/GCP regulations while leading teams and external partners. Proficient in project planning, budget management, and maintaining inspection readiness throughout the study lifecycle.

Highest-signal resume keywords

Clinical Research ManagementTeam LeadershipRegulatory ComplianceProject PlanningBudget Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchStudy DeliveryData CollectionSite SelectionTrial Master File ManagementFeasibility AssessmentSOP DevelopmentMonitoring Reports ReviewQuery ResolutionClinical Study Report Execution

Soft Skills

MentoringCollaborationProblem SolvingCommunicationQuality Improvement

Tools & Technologies

MS OfficeProject Planning ApplicationsStudy Systems

Industry Keywords

BiotechPharmaCROICHGCPInspection ReadinessClinical OperationsRegulatory SubmissionsVendor ManagementClinical Trials

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Accountable for regional study delivery with inspection readiness quality, within agreed timelines and budget
Act as regional lead for multiple studies across an indication or program
Lead regional clinical operations teams and external regional partners
Serve as escalation point for regional study issues
Align regional deliverables with overall study goals
Develop regional tools, work instructions and SOPs
Lead regional planning and management of clinical studies from feasibility through closeout
Manage study start-up and recruitment timelines and track progress
Drive trial feasibility, country allocation and site selection
Coordinate local adaptations of global study documents and regulatory/ethics submissions
Maintain regional and country information in study systems
Collaborate with CRAs to ensure study execution and review monitoring reports
Ensure regional and country-level Trial Master File creation, maintenance and quality control
Provide input on clinical supplies, drug inventories, labels and comparator drug status
Manage regional data collection, data entry and query resolution
Support Clinical Study Report planning and execution
Monitor compliance with protocol, SOPs, ICH/GCP and applicable regulations
Ensure inspection readiness and prepare sites for audits and inspections
Lead quality improvements and share best practices
Select and manage regional vendors
Manage regional study budgets
Address investigator fees, site payments and patient travel reimbursement
Manage regional resource needs and utilization
Provide performance feedback and mentor junior team members

Requirements

What you’ll need

Bachelor’s Degree in a scientific or healthcare discipline required
Higher Degree preferred
6 or more years of progressive experience in clinical research within biotech, pharma or CRO industry
Proven experience in clinical research, including relevant experience as team lead in clinical functions
Experience as CRA preferred
MS Office proficiency
Project Planning Applications proficiency
Relevant clinical operations experience may qualify for exceptions to the degree requirement
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
Employee Stock Purchase Plan
Medical insurance
Dental insurance
Vision insurance
401(k)
FSA/HSA
Life insurance
Paid Time Off
Wellness benefits
Reasonable accommodation during the application process