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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in clinical project management, ensuring compliance with FDA regulations and Good Clinical Practice (GCP). Proficient in developing clinical project plans and managing cross-functional collaborations to achieve quality data and efficient enrollment.
Highest-signal resume keywords
Clinical Research ExperienceProject Management PracticesFDA Regulations KnowledgeGood Clinical Practice (GCP)Clinical Trial Management Systems
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 Project ManagementRegulatory Start-Up ManagementData Quality AssuranceTimeline ManagementBudget ManagementPerformance MonitoringStudy Document OrganizationStatus ReportingIssue ResolutionTraining and Mentoring
Soft Skills
CollaborationDecision-MakingProblem-SolvingCommunicationLeadership
Tools & Technologies
Clinical Trial Management SystemsDatabasesTracking Tools
Industry Keywords
Medical Device SectorSaaS SectorClinical OperationsSite ActivationsEnrollment Processes
About the role
Key responsibilities & impact- Oversee start-up, maintenance/operations, and close-out for assigned research projects
- Manage project operations to achieve quality data and efficient enrollment meeting contractual requirements
- Complete activities ensuring sponsor oversight of sites in accordance with GCP, regulations, and project requirements
- Lead assigned study program activities within timeline, quality, and budget expectations
- Develop and maintain clinical project plans, including Clinical Operations and Regulatory Start-Up Management Plans
- Maintain clinical trial management systems, databases, tracking tools, timelines, and project plans
- Organize study documents and deliver status reports
- Collaborate with Clinical and cross-functional Product, Life Sciences, Legal, and Finance partners
- Resolve issues, make decisions within scope, and escalate appropriately
- Train and inform colleagues about study management and share best practices
- Improve Viz clinical study management processes, site activations, and enrollments
Requirements
What you’ll need- At least 6 years of clinical research experience, preferably in the medical device and/or SaaS sector
- Bachelor's degree in a scientific discipline or educational equivalent; other qualifications considered
- Competent knowledge of clinical study project management practices and terminology
- Proven ability to work through others to deliver results to quality and timeline metrics, including monitoring performance and providing feedback
- Available to travel as needed, up to 30%, and able to manage travel plans
- Knowledge of FDA regulations and Good Clinical Practice (GCP) preferred
- U.S. work authorization without requiring sponsorship, now or in the future
Benefits
Comp & perks- Equity
- Performance-based bonus
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- Generous vacation
- Flexible remote work model
- Mission-driven work
- Team collaboration and innovation-focused environment
