Clinical Study Manager

Job not on LinkedIn

🔥 7 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $102k - $162k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Philips

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare • Healthcare Insurance • Biotechnology

Philips is a global health technology company committed to improving people's health and well-being through meaningful innovation. They focus on various domains including personal health, diagnosis and treatment, and connected care, striving to provide advanced technologies and solutions that enhance health outcomes for individuals and healthcare providers alike.

📋 Description

• 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

• 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

• 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