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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in conducting and overseeing clinical studies, ensuring compliance with regulatory standards, and improving study efficiency through data review and process enhancements. Proficient in collaborating with cross-functional teams and managing study progress against established milestones and budgets.
Highest-signal resume keywords
Clinical Research ExecutionMedical Device Industry KnowledgeISO 13485 FamiliarityEDC ProficiencyGCP Compliance
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 Trial DesignRegulatory ComplianceData Quality ImprovementSite AssessmentMonitoring ActivitiesProject Documentation ReviewRisk IdentificationIssue ResolutionContinuous ImprovementBudget Management
Soft Skills
Attention to DetailLearner MindsetCoachability
Tools & Technologies
EDCETMFCTMS
Industry Keywords
ISO 14155ICH GuidelinesFDA RequirementsPhilips ProceduresClinical StudiesBiostatisticsData ManagementQuality Assurance
About the role
Key responsibilities & impact- Conduct and oversee all aspects of clinical studies
- Ensure compliance with regulatory standards and Philips procedures
- Perform site assessments, monitoring, training, and close-out activities
- Serve as a subject matter expert for study sites and investigators
- Guide sites and investigators on protocol requirements, study procedures, and regulatory expectations
- Review project documentation for accuracy and compliance
- Improve study efficiency and data quality through process improvements, data review, and verification
- Collaborate with Clinical, Medical, Biostatistics, Data Management, Regulatory, Quality, R&D, and other internal teams
- Monitor study progress against milestones, timelines, and budgets
- Identify risks, resolve issues, and drive continuous improvement
- Provide updates to senior management
- Ensure readiness for audits and achievement of program objectives
Requirements
What you’ll need- 5+ years of experience in execution of clinical research; experience in the medical device industry preferred, or pharma, biotech, academia, or government research
- Knowledge of medical device clinical trial design and best practices strongly preferred
- Familiarity with ISO 13485, ISO 14155, and ICH/GCP guidelines preferred
- Bachelor's or master's degree in a related field required
- Doctorate degree or higher preferred
- Knowledge of ISO, GCP, FDA requirements and Philips procedures
- Proficiency with EDC, eTMF, and CTMS
- Strong attention to detail
- Learner mindset and coachability
- Ability to perform minimum physical, cognitive, and environmental job requirements with or without accommodation
- Up to 10% travel based on business needs
- Must be based in the local Pittsburgh, Pennsylvania area
- US work authorization required; no current or future visa sponsorship
- Must be able to work without company relocation benefits
Benefits
Comp & perks- Annual incentive bonus
- Sales commission
- Long-term incentives
- Generous PTO
- 401k with up to 7% match
- HSA with company contribution
- Stock purchase plan
- Education reimbursement
- Comprehensive Philips Total Rewards benefits program