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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Trial Site Management and adherence to Good Clinical Practice (GCP) guidelines, with strong organizational skills and the ability to build and maintain stakeholder relationships. Proficient in managing site qualification activities and ensuring compliance with relevant regulatory standards.
Highest-signal resume keywords
Clinical Trial Site ManagementGood Clinical Practice (GCP)Stakeholder Relationship ManagementQuality Management System (QMS)Regulatory Compliance Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site Qualification ActivitiesData Query ManagementClinical Imaging KnowledgeProject Tracking and ReportingOperational Efficiency Improvement
Soft Skills
Organizational SkillsTime ManagementInterpersonal SkillsProblem SolvingEffective Communication
Certifications & Qualifications
Recent GCP Training
Industry Keywords
ISO 27001ISO 9001ISO 1348521 CFR Part 11Clinical Operations
About the role
Key responsibilities & impact- Conduct Qureight site qualification activities, including site evaluation, training and scanner qualification, to ensure timely onboarding of priority clinical study sites
- Provide proactive and effective site-facing communications to support clinical trial sites in completing site qualification activities before planned activation dates
- Manage designated site activities post site qualification, including query management
- Raise data queries with site staff and manage them through completion in collaboration with data management colleagues
- Serve as point of contact for assigned clinical sites and escalate for guidance and support when needed
- Respond to and resolve inbound support requests in line with SOPs
- Communicate with all stakeholders professionally and promptly
- Track and report project and site milestones and maintain internal project systems
- Support image check (QC) processes for assigned projects in line with SOPs
- Learn about and develop expertise in CT
- Coordinate site onboarding activities as site qualification lead when necessary
- Maintain essential site-facing documents
- Participate in clinical project kick-off meetings where appropriate
- Work according to GCP guidelines, relevant regulations, ISO27001 standards and data privacy regulations
- Drive continuous improvement and operational efficiency
- Build relationships with sites, sponsors, customers and Qureight stakeholders
- Support general Clinical Operations activities as needed
Requirements
What you’ll need- Demonstrable experience in clinical trial site management
- Demonstrated experience with clinical imaging, e.g. CT or MRI is desirable but not essential
- Strong organisational and time management skills with ability to prioritise tasks effectively
- Demonstrated ability to cultivate and maintain key stakeholder relationships, both internally and externally
- Knowledge of ICH Good Clinical Practice (GCP) with evidence of recent training
- Experience working within a Quality Management System (QMS), e.g., ISO 9001, ISO 13485 is desirable
- Knowledge of relevant regulatory, compliance and industry standards, e.g. 21 CFR Part 11, is desirable
- Strong interpersonal skills with a high proficiency in written and verbal communications
- Track record of working effectively and problem solving in a highly technical and innovative environment, demonstrating a good attention to detail
- Evidence of a can-do attitude with a tenacity and drive to achieve objectives
Benefits
Comp & perks- Annual bonus plan
- Private medical insurance
- Life insurance
- Cycle-to-work scheme
- Contributory pension scheme
- Equity
- 28 days’ holiday allowance
- 25 days’ annual leave
- 3 additional company days between Christmas and New Year
- Bank holidays
- Enhanced family leave
- Diverse, multidisciplinary work environment
- Equal opportunities employer
- Application and selection process adjustments available
