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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing global clinical trials, ensuring compliance with regulatory standards, and implementing effective patient recruitment strategies. Proficient in overseeing CROs and vendors while maintaining high-quality study documentation and operational plans.
Highest-signal resume keywords
Clinical Trial ManagementGood Clinical Practice (GCP)Electronic Patient-Reported Outcomes (eCOA)Regulatory ComplianceRisk Management
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 ManagementRegulatory ComplianceRisk ManagementData AnalysisPatient Recruitment StrategiesStudy DocumentationMonitoring Visit ReportsOperational TrackersBudget ManagementClinical Research Methodologies
Soft Skills
CommunicationRelationship BuildingProblem SolvingTeam CollaborationStakeholder Engagement
Industry Keywords
Pharmaceutical IndustryBiotechnologyCRO IndustryFDA RegulationsICH GuidelinesClinical ResearchWomen’s HealthImmunologyDermatologyPhase II–III Trials
About the role
Key responsibilities & impact- Independently manage all operational aspects of assigned Phase II–III global clinical trials from startup through closeout
- Ensure adherence to protocols, regulatory requirements, and ethical standards
- Oversee CROs and vendors against study goals, regulatory standards, and timelines
- Develop and maintain study-level operational, monitoring, communication, and risk-management plans
- Review monitoring visit reports and ensure Trial Master File quality control
- Maintain study documentation and operational trackers for Sponsor oversight
- Implement patient recruitment and retention strategies with sites and CROs
- Partner with legal and finance teams on study budgets, insurance adequacy, privacy and data-protection protocols, and contracts
- Identify operational risks and implement mitigation and contingency plans
- Support clinical-data analysis, troubleshooting, interpretation, reporting, and stakeholder communication
- Monitor industry developments, regulatory changes, and clinical research methodologies
- Build relationships with cross-functional teams, CROs, vendors, and investigator sites
- Communicate with sites and stakeholders on sensitive health topics while protecting participant safety and dignity
Requirements
What you’ll need- Bachelor’s Degree in life sciences, pharmacology, or related field
- 5 years of direct experience in clinical trial management within the pharmaceutical, biotechnology, or CRO industry
- Clinical trial management experience in an industry sponsor setting
- Experience configuring, implementing, and managing electronic patient-reported outcomes (eCOA) systems, including compliance verification and data quality oversight
- Good working knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and other regulatory requirements in clinical research
- Familiarity with clinical trial regulatory filing requirements across major regions (US, EU, UK, etc.)
- Ability to travel up to 20% per month as needed
- Legal authorization to work in the U.S. required
- Must not require employment visa sponsorship
- Experience in women’s health, pain, immunology, and/or dermatology studies is a plus
- Advanced degree (MSc., Ph.D., PharmD, MD) is welcome but not required
Benefits
Comp & perks- Medical insurance
- Dental insurance
- Vision insurance
- Paid time off
- Unlimited vacation
- Parental leave
- Employee assistance program
- Voluntary life and disability insurance
- Annual bonus potential
- 401(k) with a generous company match
- Equity
- Home-office remote work arrangement
