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Clinical Trial Manager
Precision For Medicine. Manage and operationally deliver clinical elements of trials, including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data cleaning, and close-out .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trials, including site selection, enrollment management, and regulatory compliance, while effectively leading cross-functional teams and mentoring team members. Proficient in clinical trial management within oncology, with a strong understanding of GCP/ICH guidelines and the clinical development process.
Highest-signal resume keywords
Clinical Trial ManagementOncology ExperienceGCP/ICH Guidelines MasteryCTMS Software ProficiencyCross-Functional Team Leadership
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 ManagementOncology ExperienceGCP/ICH GuidelinesMedical TerminologyData CleaningMonitoring PlanningEnrollment ManagementSite EngagementRegulatory DocumentationTrial Deliverables Execution
Soft Skills
Effective CommunicationMentoringProblem-SolvingRelationship BuildingTeam Collaboration
Tools & Technologies
MS OfficeMS ProjectPowerPointCTMSETMFEDCIXRS
Industry Keywords
Clinical DevelopmentCROPharmaBiotechClinical Lead Role
About the role
Key responsibilities & impact- Manage and operationally deliver clinical elements of trials, including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data cleaning, and close-out
- Execute assigned trials successfully and ensure completion of trial deliverables
- Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trials in collaboration with cross-functional team members
- Mentor and train team members
- Identify challenges to study timelines and deliverables and propose creative action plans to the team and sponsor
- Lead CRAs in establishing site relationships and overseeing monitoring, regulatory, investigational product, site payment, and site correspondence activities
- Maintain focus on study priorities through cross-functional partnerships and effective communication to achieve client satisfaction
- Serve as the central intelligence hub for managed studies and lead CRAs across multiple countries
Requirements
What you’ll need- Bachelor’s degree or equivalent combination of education/experience in science or health-related field, including experience in oncology
- Demonstrable experience leading clinical aspects of studies across multiple countries in a CRO, Pharma, or Biotech company in a dedicated clinical lead role
- Significant clinical trial management experience in oncology
- Working knowledge of GCP/ICH guidelines and the clinical development process
- Availability for domestic and international travel, including overnight stays
- Must communicate effectively in English
- Demonstrated computer skills with MS Office, MS Project, and PowerPoint
- Software experience with CTMS, eTMF, EDC, and IXRS
- Ability to develop positive working relationships with internal and external organizations
- Core understanding of medical terminology and clinical trial activities related to clinical development plan execution
- Mastery of ICH-GCP, relevant Precision SOPs, and regulatory guidance, with ability to implement them
- Must be legally authorized to work in the country of employment without employer sponsorship