Clinical Study Manager

🕒 2 days ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $102k - $182k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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Philips

WebsiteLinkedInAll Job Openings

10,000+ employees

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance • Biotechnology • Medical Devices

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

• Oversees the execution and regulatory compliance of clinical studies • Conducts and oversees all aspects of clinical studies, ensuring strict compliance with regulatory standards (ISO, GCP, FDA) and Philips procedures • Optimizes study efficiency and data quality through process improvements • Collaborates with Clinical, Medical, Biostatistics, Data Management, Regulatory, Quality, R&D, and other internal teams • Monitors study progress against milestones, timelines, and budgets; proactively identifies risks and resolves issues

🎯 Requirements

• 5+ years of experience in execution of clinical research in the medical device industry (preferred), pharma, biotech, academia, or government research • knowledge of medical device clinical trials design and best practices (strongly preferred) • familiarity with relevant medical device standards preferred (ISO 13485, 14155, ICH/GCP guidelines, etc.) • bachelor's degree or higher, master's preferred • strong attention to detail • learner mindset • coachable • Up to 10% travel required based on business needs • Must be based in the local Pittsburgh, PA area for proximity to study site locations.

🏖️ Benefits

• PTO • 401k (up to 7% match) • HSA (with company contribution) • stock purchase plan • education reimbursement