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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Oncology clinical trial monitoring, including solid tumor trials and regulatory compliance. Proficient in site management, training, and fostering relationships with key stakeholders to ensure successful trial execution.
Highest-signal resume keywords
Oncology Clinical Trial MonitoringSolid Tumor ExperienceVeeva Systems UtilizationGxPs ExpertiseRisk-Based Monitoring
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site ManagementMonitoring ActivitiesSite QualificationSite InitiationInterim MonitoringClose-Out VisitsSite CAPA PlansTraining Site StaffDocument CollectionTMF Reconciliation
Soft Skills
Relationship BuildingMentoringProblem SolvingCollaborationCommunication
Tools & Technologies
Veeva Systems
Industry Keywords
Clinical TrialsOncologyGCPsIRBEthics CommitteeKRI MetricsComplianceFunctional ServicesEarly Development TrialsPhase III Trials
About the role
Key responsibilities & impact- Perform site management activities to support the client's Oncology site success and maintain continuous inspection readiness
- Act as the primary contact between the client's clinical trial team and sites
- Perform remote and on-site monitoring/co-monitoring visits, including Site Qualification, Site Initiation, Interim Monitoring, and Close-Out Visits
- Perform oversight activities to assess monitoring quality and train or mentor less experienced CRAs
- Document monitoring activities and submit or approve visit reports
- Manage site essential document collection and TMF reconciliation with site files
- Support local IRB/Ethics Committee submissions and confirm approvals
- Review site KRI metrics, issues, and action items to detect trends and ensure prompt resolution
- Determine root causes and develop or implement site CAPA plans
- Deliver training on protocols, SOPs, GCPs, and regulations
- Support sites and the client's regulatory inspections
- Contribute to site identification, feasibility, qualification, and activation activities
- Lead site engagement initiatives and foster relationships with key Oncology sites and networks
Requirements
What you’ll need- Bachelor’s degree (scientific field preferred)
- 5+ years monitoring clinical trials independently conducting on-site and remote monitoring visits
- At least 2 years monitoring solid tumor clinical trials
- 1+ years early development oncology trial experience and/or Phase III Oncology trial experience
- Solid tumor clinical trial experience is required
- Experience utilizing Veeva systems is highly preferred
- Demonstrated experience developing/maintaining site relationships and securing compliance
- Expertise in GxPs and Oncology monitoring techniques, including Risk-Based Monitoring, and terminology
- Experience collaborating with sites from initial engagement through close-out phases
- Experience activating sites
- Experience training site staff
- Experience supporting sites and/or sponsors in regulatory inspections
- Experience working within a Functional Services or in-house monitoring model is preferred
- Willing to travel up to 50%
- Legal right to work in the country where the role is based
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways