Regional Clinical Study Manager

BeOne Medicines

. Accountable for regional study delivery with inspection-ready quality, agreed timelines and budget .

Posted 10/2/2026full-timeRemote • United StatesMid-LevelSenior💰 $118,600 - $158,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing regional clinical studies, ensuring compliance with ICH/GCP and regulatory standards, and leading cross-functional teams to achieve study goals. Proficient in clinical operations, study start-up, and data management while mentoring junior team members.

Highest-signal resume keywords

Clinical Research ExperienceTeam Leadership in Clinical FunctionsRegulatory Submissions KnowledgeStudy Start-Up and Recruitment ManagementICH/GCP Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study DeliveryData CollectionQuery ResolutionTrial Master File ManagementProject Planning Applications ProficiencyStudy Budget ManagementSite SelectionFeasibility AssessmentRegulatory ComplianceClinical Operations

Soft Skills

MentoringCollaborationProblem-SolvingCommunicationLeadership

Tools & Technologies

MS OfficeClinical Study SystemsProject Planning Applications

Industry Keywords

BiotechPharmaCROSOPsInspection ReadinessClinical OperationsCountry AllocationSite PaymentsInvestigator FeesPatient Travel Reimbursement

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Accountable for regional study delivery with inspection-ready quality, agreed timelines and budget
Lead the regional clinical operations team and oversee external regional partners
Act as escalation point for regional study issues
Align regional deliverables with overall study goals
Lead regional operations meetings and represent the regional study team at internal and cross-functional meetings
Plan and manage assigned clinical studies from feasibility through regional closeout
Generate, manage and maintain regional study start-up and recruitment timelines
Drive trial feasibility, country allocation and site selection with relevant stakeholders
Provide regional input on global study plans
Coordinate local adaptations of global study documents and support timely regulatory and EC/IRB submissions
Ensure study submissions in assigned countries in collaboration with study start-up and regulatory teams
Maintain regional and country information in study systems and tools
Collaborate with CRAs on site execution and review/sign off monitoring reports
Ensure country and site-level Trial Master Files are created, maintained and quality-checked
Provide input on regional drug inventories, local drug labels, comparator drug approvals and reimbursement status
Manage regional trial data collection, data entry and query resolution
Support Clinical Study Report planning and execution
Handle escalated site issues and monitor compliance with protocols, SOPs, ICH/GCP and regulations
Ensure regional inspection readiness and implement solutions to study issues
Prepare sites for audits and inspections and drive responses to findings
Share learnings and best practices across teams
Lead improvements and contribute to work instructions and SOPs
Select and manage regional study vendors with sourcing
Manage regional study budgets
Coordinate investigator fees, site payments and patient travel reimbursement
Identify regional resource needs and contingency plans
Monitor regional resource utilization
Provide performance feedback and mentor junior team members as needed

Requirements

What you’ll need

4 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 is preferred
Bachelor’s Degree in a scientific or healthcare discipline required; higher degree preferred
Exceptions might be made for candidates with relevant clinical operations experience
MS Office proficiency
Project Planning Applications proficiency
Knowledge of clinical study delivery, clinical operations, study start-up, recruitment, feasibility, country allocation, site selection, regulatory submissions, TMF management, data collection, query resolution, ICH/GCP, SOPs and applicable regulations
Ability to travel as required by 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 for applicants with disabilities