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Clinical Trial Manager
Precision Medicine Group. Manage and operationally deliver clinical elements within trials, including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning, and close-out .
Core Competencies
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Demonstrates expertise in managing clinical trials, including site selection, enrolment management, and regulatory compliance, while effectively leading cross-functional teams and fostering strong relationships with stakeholders. Proficient in oncology clinical trial management with a solid understanding of GCP/ICH guidelines and clinical development processes.
ATS Keywords
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About the role
Key responsibilities & impact- Manage and operationally deliver clinical elements within 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 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 be able to communicate effectively in English
- Demonstrated computer skills in 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, relevant Precision SOPs, and regulatory guidance, with ability to implement
- Candidates must be legally authorized to work in the country of employment without employer sponsorship
Benefits
Comp & perks- Remote work option
- Regular full-time employment
- Professional growth and continued development support
- Mentoring and training opportunities
- Opportunity to work on oncology and rare disease clinical trials
- Equal Opportunity Employer
- Reasonable accommodation available for applicants with disabilities