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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, with a strong focus on oncology. Proven ability to lead cross-functional teams and mentor team members while ensuring successful trial execution and client satisfaction.
Highest-signal resume keywords
Clinical Trial ManagementOncology ExperienceGCP/ICH Guidelines KnowledgeCTMS Software ExperienceTeam 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 ManagementSite SelectionEnrollment ManagementData CleaningRegulatory DocumentationMedical TerminologyMonitoring PlanningCreative Problem SolvingTrial Deliverables ExecutionCross-Functional Collaboration
Soft Skills
Effective CommunicationMentoringRelationship BuildingTeam SupportClient Satisfaction Focus
Tools & Technologies
MS OfficeMS ProjectPowerPointETMFEDCIXRS
Industry Keywords
CROPharmaBiotechClinical Development ProcessPrecision SOPs
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 provide creative action plans to the team and sponsor
- Lead CRAs in establishing site relationships and overseeing monitoring, regulatory, IP, site payment, and site correspondence activities
- Maintain focus on study priorities through cross-functional partnerships and communication to achieve client satisfaction
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 be able to communicate effectively in English
- Demonstrated computer skills with MS Office, MS Project, and PowerPoint
- Software experience with CTMS, eTMF, EDC, and IXRS
- Demonstrated 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 knowledge of ICH-GCP, Precision SOPs, and regulatory guidance, with ability to implement