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Study Monitoring Lead, Clinical Operations, Oncology Therapy Area
OrionStudy Monitoring Lead overseeing operational oversight of oncology clinical trials at Orion Corporation. Focused on study feasibility, site management, and regulatory compliance.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in clinical trial operations, particularly in oncology studies, with a strong focus on site management, feasibility assessment, and adherence to GCP and regulatory standards. Proven ability to collaborate effectively with cross-functional teams and manage operational metrics for successful study execution.
Highest-signal resume keywords
Clinical Operations ExperienceOncology Study MonitoringSite Management CoordinationKnowledge of ICH-GCPFeasibility Assessment
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ExecutionStudy Feasibility ActivitiesSite Activation Performance MonitoringData Quality AssuranceClinical Study Plan PreparationPatient-Facing Material ValidationOperational Metrics TrackingRisk Identification and ResolutionRegulatory ComplianceSOP Adherence
Soft Skills
Collaboration SkillsEffective CommunicationProblem-SolvingDetail-OrientedProactive Approach
Certifications & Qualifications
Master Degree in Life Sciences
Industry Keywords
CRO OversightSite EngagementInspection ReadinessClinical Trial ProcessesInternational Travel
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Accountable for the day-to-day operational oversight of clinical trial execution
- Oversee study feasibility activities and site management coordination.
- Monitor site activation performance and ensure site enrollment and data quality.
- Prepare and validate clinical study plans and patient-facing materials.
- Support oversight of CROs and vendors in monitoring and site management.
- Coordinate and track key operational metrics.
- Partner with data management, safety, and regulatory teams for smooth execution of study activities.
- Identify risks and operational issues for timely resolution or escalation.
- Ensure adherence to GCP, protocol, and SOPs in daily execution.
Requirements
What you’ll need- Master Degree in life sciences or related field.
- 5+ years of clinical operations experience, with 3+ years in monitoring oncology studies as CRA/ clinical trial monitoring and/or study coordination at site level.
- Demonstrated experience in feasibility, site selection, and site management coordination/oversight.
- Strong knowledge of ICH-GCP and global clinical trial processes, including inspection readiness.
- Team-oriented with strong collaboration skills with effective communication skills, and site engagement capabilities.
- Hands-on, pragmatic, detailed-oriented, proactive problem-solving with solution-oriented approach and analytical skills.
- Ability to travel internationally as needed.
Benefits
Comp & perks- Continuous learning investment
- Impact on lives through innovative products
- Building teamwork and low hierarchies