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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical project management, including study start-up activities, patient recruitment, and compliance with ICH-GCP and regulatory requirements. Proficient in coordinating clinical teams and managing project timelines while ensuring quality and process improvement.
Highest-signal resume keywords
Clinical Research Operations ExperienceICH-GCP ComplianceProject Management SkillsStrong Communication SkillsMicrosoft Office Proficiency
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 Research Associate ExperienceStudy Start-Up ActivitiesPatient RecruitmentData CleaningOn-Site Monitoring ExperienceResource ManagementContingency PlanningAudit PreparationDatabase Lock CoordinationProcess Improvement Initiatives
Soft Skills
Organization SkillsProblem-Solving SkillsAttention to DetailAbility to Manage Multiple TasksCollaboration Skills
Tools & Technologies
Microsoft ExcelMicrosoft WordMicrosoft PowerPointMicrosoft OutlookWebExParexel Systems
Industry Keywords
Clinical Trial ProcessesRegulatory RequirementsLife Science DegreeNursing QualificationLocal Language Proficiency
About the role
Key responsibilities & impact- Coordinate and direct clinical project team members on small to midsize studies
- Provide productivity targets, performance feedback, and input to study-specific training
- Manage study start-up activities, including project plans, site selection strategy, monitoring plans, and patient recruitment and retention plans
- Monitor study timelines, patient recruitment, patient retention, and data cleaning
- Address escalated site issues, identify potential problems early, and support contingency planning
- Communicate with internal and external customers, sponsors, investigational sites, and third-party vendors
- Evaluate resourcing needs and monitor resource use across the project life cycle
- Prepare for and participate in audits and inspections
- Support maintenance and quality checks of central files
- Ensure compliance with ICH-GCP, local regulatory requirements, Parexel SOPs, work instructions, and operational guidelines
- Collaborate on database lock, project close-out, and archiving activities
- Support process improvement initiatives and contribute lessons learned at study close-out
Requirements
What you’ll need- Degree in a life science or a nursing qualification, or relevant clinical or clinical management experience
- Substantial relevant work experience in clinical research operations, such as Clinical Research Associate (CRA) experience or equivalent
- Knowledge of International Council for Harmonisation (ICH) Good Clinical Practice (GCP), regulatory requirements, and clinical trial processes across the full project life cycle
- Strong command of written and spoken English, with local language proficiency as required
- Strong communication, organization, and problem-solving skills
- Ability to manage multiple tasks and prioritize workload with attention to detail
- Proficiency with Microsoft Office (Excel, Word, PowerPoint, Outlook) and WebEx
- Ability to become proficient with Parexel systems
- Coordinating experience, preferably gained in a Senior CRA or Senior CMA position
- On-site monitoring experience
- Local language proficiency for assigned countries
- Ability to travel as required
Benefits
Comp & perks- Flexible work arrangements
- Growth opportunities
- Continuous learning opportunities
- Career path exploration and skill expansion
- Diverse teams
- Ability to travel as required
