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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research operations, team leadership, and financial management, with a strong focus on compliance with FDA regulations and ICH-GCP standards. Proven ability to enhance site performance through effective coaching, strategic planning, and data-driven decision-making.
Highest-signal resume keywords
Clinical Research Operations ManagementTeam Leadership and DevelopmentFDA Regulations and ICH-GCP KnowledgeFinancial Management and BudgetingSite Performance Improvement
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 ResearchSite Operations ManagementBudgeting and ForecastingPerformance Metrics MonitoringAudit ReadinessData AnalysisEnrollment Strategy DevelopmentProtocol ComplianceRisk AssessmentTalent Development
Soft Skills
Strong CommunicationCoaching and MentoringRelationship BuildingDecision-MakingProblem-Solving
Industry Keywords
Clinical TrialsTherapeutic AreasMulti-Site NetworksSite Management OrganizationsClinical AffairsPrincipal Investigator OversightPatient CarePhysician CollaborationSafety ReportingInvestigational Product Handling
About the role
Key responsibilities & impact- Lead, coach, and develop Site Directors and Site Managers, setting clear goals, KPIs, and expectations
- Step in as Interim Site Director, or arrange solid coverage, when a site is in transition
- Monitor site operations and performance metrics to improve efficiency, quality, enrollment, and protocol compliance
- Roll out network-wide processes, systems, and SOPs consistently across sites
- Partner with site leadership on budgeting, forecasting, FTE planning, and margin management
- Review financial and operational reports to spot risks and trends early
- Work with Marketing and Participant Recruitment to strengthen enrollment strategy and forecasting
- Support Business Development with feasibility input and site capability assessments
- Work with Quality, Regulatory, and Clinical Affairs on audit readiness and principal investigator oversight
- Build relationships with principal investigators and serve as the regional escalation point for investigator and sponsor concerns
- Support hiring, onboarding, and staffing decisions for site-level teams
- Lead mid-year and annual performance reviews for direct reports
Requirements
What you’ll need- Bachelor’s degree in science, nursing, or a related field (equivalent combination of education, experience, and training considered)
- 7-10+ years of progressively responsible experience in clinical research or related operations
- Prior experience managing teams or site operations; 5+ years of people management preferred
- Clinical experience across two or more therapeutic areas
- Experience with multi-site networks, SMOs, TMOs, or hospital-owned physician networks preferred
- Strong knowledge of FDA regulations, ICH-GCP, safety reporting, and investigational product handling
- Healthcare background in a line of business with direct patient care and physician collaboration
- Comfortable making financially sound, defensible business decisions
- Strong communicator across sites, sponsors, CROs, and regulators
- Data-driven, with a track record of developing and coaching talent
Benefits
Comp & perks- 401(k)
- 401(k) matching
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
- Competitive wages