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Clinical Trial Manager
Precision For Medicine. Manage and operationally deliver clinical elements of trials, including site selection, start-up, enrolment 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, monitoring, and regulatory compliance, with a strong focus on oncology. Proven ability to lead cross-functional teams and maintain effective communication to ensure successful trial execution and client satisfaction.
Highest-signal resume keywords
Clinical Trial ManagementOncology ExperienceGCP/ICH Guidelines MasteryCTMS Software ProficiencyTeam Leadership and Mentoring
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 PlanningRegulatory DocumentationEnrolment ManagementSite EngagementTrial Deliverables Execution
Soft Skills
Effective CommunicationProblem-SolvingRelationship BuildingMentoringCreative Action Planning
Tools & Technologies
MS OfficeMS ProjectPowerPointCTMSETMFEDCIXRS
Industry Keywords
CROPharmaBiotechClinical Development ProcessRegulatory Guidance
About the role
Key responsibilities & impact- Manage and operationally deliver clinical elements of trials, including site selection, start-up, enrolment 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 functional team members
- Mentor and train team members
- Identify challenges to study timelines and deliverables and offer creative action plans to the team and sponsor
- Lead CRAs in site relationships and oversight of monitoring, regulatory, IP, site payment, and site correspondence activities
- Maintain focus on study priorities through cross-functional partnerships and effective 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 of ICH-GCP, Precision SOPs, and regulatory guidance, with ability to implement them
- Legally authorized to work in the country of employment without employer sponsorship