Lead global execution of multiple Phase IIIII clinical trials in oncology (non-lung)
Build, manage, mentor, and provide line management for Clinical Operations staff (>20 members with skip reports), including study management team leaders, clinical trial managers, CRAs and contractors
Directly manage the global Study Start-Up team, overseeing essential documents, site budgets, and site contract negotiations
Establish and drive SSU performance metrics, including site activation cycle times, essential document completeness, and budget and contract turnaround time
Monitor progress, enrollment, quality, timelines, and budgets across multiple concurrent studies; proactively manage risks
Timely escalation of risks to the Head of Clinical Operations.
Lead CRO governance, including selection, contracting, performance monitoring, KPIs, risk management, escalation pathways, and executive reviews to ensure quality, timelines, and budget adherence
Manage and oversee Randstad Services providing unblinding monitoring support, ensuring compliance, quality, timelines, and clear separation of blinded and unblinded activities
Partner cross-functionally with Clinical Development, Medical Affairs, Regulatory, Biometrics, Safety, CMC, Quality, and Project Management across regions
Support SOP development, review, and implementation to ensure consistency, compliance, and inspection readiness across clinical operations
Support preparation of clinical components for global regulatory submissions and health authority inspections
Implement fit-for-purpose global clinical operations processes, metrics, and oversight models appropriate for a growing biotech company
Partner with Business Operations and IT to identify and implement technological solutions to replace manual processes and improve data transparency.
All other duties as assigned

Requirements

Bachelors degree in life sciences (advanced degree preferred)
Minimum of 15+ years of clinical operations expertise spanning biotech, pharma, and CRO organizations, with the last decade dedicated to overseeing complex phase III oncology trials from startup through completion
Proven track record of successfully managing direct reports and leading cross-functional teams through influence in a matrixed environment
Demonstrated leadership over the last decade by managing teams exceeding 20 direct and skip-level reports, driving performance, development, and organizational alignment.
Proven leadership of multiple global Phase IIIII trials
Strong experience in CRO governance, including oversight frameworks, KPIs, risk escalation, and quality monitoring
Experience overseeing unblinded monitoring models and external service providers
Experience in SOP development, review, and implementation
Deep knowledge of ICH, GCP, and global clinical trial regulations
Strong experience with site budgets, contracts, CRO oversight, and vendor management
Ability to operate strategically while remaining hands-on and execution-focused
Demonstrated experience in process improvement and the application of technology to streamline clinical operations.
Willingness to travel internationally as needed.

Benefits

Bonuses
Stock options
Health insurance
Professional development opportunities

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical operationsPhase III clinical trialsCRO governanceSOP developmentsite budget managementcontract negotiationrisk managementperformance metricsregulatory submissionsprocess improvement

Soft Skills

leadershipmentoringcross-functional collaborationstrategic thinkingexecution focusteam managementorganizational alignmentcommunicationproblem-solvinginfluence