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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, ensuring compliance with GCP guidelines, and managing stakeholder relationships. Proficient in developing study management documentation and overseeing project financials while mentoring junior team members.
Highest-signal resume keywords
Clinical Research ExperienceProject ManagementGood Clinical Practice (GCP)Stakeholder Relationship ManagementQuality Management System (QMS)
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 ManagementProject DeliveryRisk ManagementFinancial TrackingRegulatory ComplianceSOP DevelopmentClinical Trial ManagementData Privacy RegulationsChange ManagementStudy Planning
Soft Skills
Interpersonal SkillsCommunication SkillsAttention to DetailProblem SolvingCan-Do Attitude
Certifications & Qualifications
Project Management QualificationICH GCP Training
Industry Keywords
Clinical TrialsImaging Clinical ResearchISO 9001ISO 1348521 CFR Part 11Lung TrialsHeart Trials
About the role
Key responsibilities & impact- Lead operational delivery of assigned customer projects and clinical studies from initiation through close out
- Ensure delivery against agreed scope and timelines
- Serve as subject matter expert for assigned studies
- Maintain oversight of study requirements, deliverables and operational performance
- Develop and maintain study plans, timelines, trackers and study management documentation
- Support clinical site managers and clinical data managers in delivering study milestones
- Collaborate with internal and external stakeholders
- Act as senior point of contact and trusted partner for assigned clients
- Establish and maintain long-term client relationships
- Lead client meetings, prepare agendas and status updates, and track actions
- Oversee study risks, issues and dependencies
- Develop mitigation and contingency strategies
- Deliver study start-up activities, including Kick-off Meetings and preparation, review and release of key study documents
- Manage project-level change and assess impacts on scope, timeline, resources and financial performance
- Oversee study financial milestones and contribute to forecasting, invoicing, reconciliation and deliverable tracking
- Deliver activities according to Qureight SOPs, GCP guidelines, ISO27001 standards, data privacy regulations and other applicable regulations
- Develop and maintain study management processes and write or review SOPs
- Support and mentor junior team members
Requirements
What you’ll need- Minimum of 4 years of clinical research experience, ideally in an imaging Clinical Research Organisation or other clinical trial delivery environment
- Experience as a project manager or study manager in clinical research is essential
- Focus on lung and heart pharmaceutical trials is desirable
- Previous experience working with clinical trial imaging is highly desirable but not essential
- Ability to cultivate and maintain key stakeholder relationships internally and externally
- Excellent knowledge of ICH Good Clinical Practice (GCP) with evidence of recent training
- Experience working within a Quality Management System (QMS), e.g. ISO 9001 or ISO 13485
- Knowledge of relevant regulatory, compliance and industry standards, e.g. 21 CFR Part 11
- Strong interpersonal skills with high proficiency in written and verbal communications
- Track record of effective work and problem solving in a highly technical and innovative environment
- 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
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 expertise