Senior CRA Functional Manager

BeOne Medicines

. Develop resourcing strategies and provide personnel oversight within the Site Management organization .

Posted 10/28/2026full-timeRemote • United StatesSenior💰 $136,400 - $181,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Clinical Operations, including personnel management, trial oversight, and compliance with GCP guidelines and country-specific regulations. Proficient in developing metrics and KPIs to drive continuous improvement and optimize site management effectiveness.

Highest-signal resume keywords

Clinical Operations ManagementGCP Guidelines CompliancePerformance ManagementMetrics DevelopmentOncology Global Trials Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical OperationsMonitoring ExperienceMetrics DevelopmentKPI DevelopmentPerformance ManagementCoachingMentoringRisk AssessmentData ManagementSite Management

Soft Skills

LeadershipCollaborationCommunicationStakeholder ManagementProblem-Solving

Tools & Technologies

Analytic PlatformsDashboard ReviewMonitoring SOPsTMF ManagementClinical Study Management Systems

Industry Keywords

ICH-GCPBeOne StandardsOncology TrialsCRO ManagementQuality Monitoring

About the role

Key responsibilities & impact

Develop resourcing strategies and provide personnel oversight within the Site Management organization
Develop metrics and KPIs for CRA staff and monitor continuous improvement using technology and analytic platforms
Lead CRA Managers and their staff, ensuring accountability for study assignments, training, and metrics review
Provide performance management, coaching, and mentoring for assigned management staff
Ensure monitoring expectations comply with monitoring SOPs, GCP guidelines, country-specific regulations, and quality and risk-based effectiveness standards
Conduct assessments, co-monitoring visits, Investigator meetings, or Booster visits as needed to evaluate CRA staff
Drive improvements to optimize effectiveness and efficiency within Site Management and the greater Americas region
Oversee monitoring quality and related metrics, including trip-report turnaround, trip-report quality, action-item management, query management, data currency, and TMF management
Manage relationships with CRO FSP line managers and respond to feedback regarding direct reports, studies, and programs
Act as escalation point for CTOMs and study teams regarding CRA-related issues and concerns
Ensure adequate monitoring allocations and relevant training for direct reports’ projects
Support BeiGene RBx strategy and engagement of direct reports
Document monitoring oversight activities according to ICH-GCP and BeOne standards
Assist with investigator and site identification
Manage site trends through dashboard review and ongoing risk assessment
Collaborate with clinical study teams and sites to deliver study milestones, including startup, recruitment, database analyses, and closeout
Establish communication with stakeholders to manage clinical delivery and report or escalate issues
Review monitoring reports for quality oversight
Support site audits and inspections and follow through on findings to resolution

Requirements

What you’ll need

BS/BA in a relevant scientific discipline
Minimum of 8-9 years of relevant Clinical Operations experience
4-5 years combining personnel and trial management experience
Minimum of 4-5 years of monitoring experience
Experience in oncology global trials preferred
Knowledge of monitoring SOPs, GCP guidelines, country-specific regulations, and quality and risk-based monitoring
Ability to develop metrics and KPIs
Ability to conduct performance management, coaching, and mentoring
Ability to manage CRO FSP line-manager relationships
Ability to work with CTOMs, Clinical Study Teams, investigators, and internal and external stakeholders
Ability to support site audits and inspections and resolve findings
Ability to follow ICH-GCP and BeOne standards

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