Clinical Study Manager

Philips

. Oversee execution and regulatory compliance of clinical studies .

Posted 10/12/2026full-timeRemote • Pennsylvania • United StatesMid-LevelSenior💰 $102,000 - $162,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in overseeing clinical studies, ensuring regulatory compliance, and managing study documentation. Proficient in utilizing clinical trial technologies and collaborating with cross-functional teams to enhance study efficiency and data quality.

Highest-signal resume keywords

Clinical Research ExecutionRegulatory Compliance (ISO, GCP, FDA)Clinical Trial Technologies (EDC, eTMF, CTMS)Medical Device Standards Knowledge (ISO 13485, ISO 14155)Project Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ExecutionRegulatory ComplianceStudy Documentation ManagementSite AssessmentsData Review and VerificationProcess ImprovementRisk Identification and ResolutionStudy MonitoringProtocol GuidanceBudget Management

Soft Skills

Attention to DetailLearner MindsetCoachabilityCollaborationCommunication

Tools & Technologies

EDCETMFCTMS

Industry Keywords

Clinical StudiesMedical Device IndustryPharmaBiotechAcademiaGovernment ResearchISO StandardsICH Guidelines

About the role

Key responsibilities & impact

Oversee execution and regulatory compliance of clinical studies
Manage study documentation, negotiations, and team priorities
Conduct and oversee clinical study activities, including site assessments, monitoring, training, and close-out
Ensure compliance with ISO, GCP, FDA, and Philips procedures
Serve as a subject matter expert for study sites and investigators
Provide guidance 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
Use clinical trial technologies including EDC, eTMF, and CTMS
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 and ensure readiness for audits

Requirements

What you’ll need

5+ years of experience in execution of clinical research in the medical device industry, pharma, biotech, academia, or government research required
Knowledge of medical device clinical trials design and best practices strongly preferred
Familiarity with relevant medical device standards, including ISO 13485, ISO 14155, and ICH/GCP guidelines, preferred
Bachelor's or master's degree required
Doctorate degree or higher in a related field preferred
Ability to perform minimum Physical, Cognitive and Environmental job requirements with or without accommodation
Strong attention to detail
Learner mindset and coachability
Up to 10% travel required based on business needs
Must be based in the local Pittsburgh, PA area for proximity to study site locations
US work authorization required
Must not require sponsorship for a work-authorized visa now or in the future

Benefits

Comp & perks

Annual incentive bonus may be offered
Sales commission may be offered
Long-term incentives may be offered
Generous PTO
401k with up to 7% match
HSA with company contribution
Stock purchase plan
Education reimbursement
Company relocation benefits will not be provided