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Clinical Trial Manager
Precision Medicine Group. 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 with a focus on oncology, ensuring compliance with GCP/ICH guidelines, and effectively communicating with cross-functional teams. Proven ability to lead and mentor teams while maintaining client satisfaction and delivering trial objectives.
Highest-signal resume keywords
Clinical Trial ManagementOncology ExperienceGCP/ICH Guidelines MasteryCTMS Software ProficiencyTeam 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 GuidelinesData CleaningMonitoring PlanningRegulatory DocumentationSite SelectionEnrolment ManagementCreative Problem SolvingMedical Terminology
Soft Skills
Effective CommunicationMentoringTeam CollaborationClient Satisfaction FocusProblem-Solving
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, 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 propose 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 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 the field of 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 the English language
- Demonstrated computer skills with MS Office, MS Project, and PowerPoint
- Software experience with CTMS, eTMF, EDC, and IXRS
- 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
- Must be legally authorized to work in the country of employment without employer sponsorship
Benefits
Comp & perks- Remote work arrangement
- Regular full-time employment
- Continued professional growth support
- Mentoring and training opportunities
- Domestic and international travel opportunities