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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading clinical research projects, managing timelines, and ensuring compliance with GCP and ISO standards. Proficient in stakeholder communication and project financial management to achieve study milestones.
Highest-signal resume keywords
Clinical Research ExperienceProject ManagementGood Clinical Practice (GCP)Quality Management System (QMS)Stakeholder Relationship Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Study ManagementRisk ManagementProject Financial TrackingClinical Trial ImagingRegulatory Compliance
Soft Skills
Interpersonal SkillsProblem SolvingAttention to DetailCommunication SkillsTenacity
Certifications & Qualifications
Project Management Qualification
Industry Keywords
ISO 27001ISO 9001ISO 1348521 CFR Part 11Clinical Operations
About the role
Key responsibilities & impact- Lead assigned customer projects and clinical studies from kick-off through maintenance and close-out
- Develop and maintain study plans, timelines, trackers and study management documentation
- Monitor study progress against milestones and identify risks, issues and dependencies
- Coordinate and lead study meetings, prepare agendas and status updates, and track actions
- Work with customers to establish project goals, objectives, requirements and expectations
- Collaborate and communicate with internal and external stakeholders
- Support clinical site managers and clinical data managers in delivering study milestones
- Deliver study start-up activities, including leading kick-off meetings and creating, reviewing and releasing key study documents
- Own and manage project-level change and risk management
- Monitor project financial milestones and work with Finance on invoicing timelines and deliverable tracking
- Deliver study management activities in accordance with Qureight SOPs, GCP guidelines, ISO27001 standards, data privacy regulations and applicable regulations
- Support Clinical Operations process improvement
- Report project financial details and milestone achievement to support invoicing and reconciliation
Requirements
What you’ll need- Minimum of 2 years of clinical research experience, ideally in an imaging Clinical Research Organisation or other clinical trial delivery environment
- Experience as a project manager or start-up specialist in clinical research is desirable, particularly in lung and heart pharmaceutical trials
- Previous experience working with clinical trial imaging is highly desirable but not essential
- Ability to cultivate and maintain key stakeholder relationships 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
- Knowledge of relevant regulatory, compliance and industry standards, e.g. 21 CFR Part 11
- Strong interpersonal skills and high proficiency in written and verbal communications
- Track record of effective work and problem solving in a highly technical and innovative environment, with good attention to detail
- Can-do attitude, tenacity and drive to achieve objectives
- Experience of, or formal qualification in, project management
- Relevant scientific or technical degree is beneficial but not essential
- CV and covering letter required
- Understanding of clinical study quality and regulatory standards
- Ability to work from the Cambridge or London office in a hybrid arrangement
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 work environment with multidisciplinary experts