Clinical Study Manager

About the role

The Clinical Study Manager will lead the execution and regulatory compliance of clinical studies for Philips Sleep & Respiratory Care, ensuring alignment with company standards and readiness for audits.

Key responsibilities

• Conduct and oversee all aspects of clinical studies, including site assessments, monitoring, training, and close‑out activities, while ensuring compliance with ISO, GCP, FDA and Philips procedures.
• Serve as a subject‑matter expert for study sites and investigators, providing guidance on protocol requirements, regulatory expectations, and reviewing documentation for accuracy.
• Optimize study efficiency and data quality through process improvements, thorough data review, and verification using EDC, eTMF and CTMS tools.
• Collaborate with Clinical, Medical, Biostatistics, Data Management, Regulatory, Quality, R&D and other internal teams to achieve project goals.
• Monitor study progress against milestones, timelines and budgets, proactively identifying risks and driving continuous‑improvement initiatives.

Required profile

• 5+ years of experience executing clinical research in the medical device industry (or pharma/biotech/academia).
• Doctorate preferred; bachelor’s or master’s degree required.
• Strong attention to detail, learner mindset and coachability.
• Willingness to travel up to 10% and be based in the Pittsburgh, PA area.

Required skills

• Knowledge of medical‑device clinical trial design and best practices.
• Familiarity with ISO 13485, ISO 14155, ICH/GCP guidelines and FDA regulations.
• Proficiency with clinical trial technologies such as Electronic Data Capture (EDC), electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS).

What we offer

• Competitive salary range $102,000‑$162,000 per year.
• Comprehensive total‑rewards benefits including generous PTO, 401(k) match up to 7%, HSA contributions, stock purchase plan and education reimbursement.
• Opportunity to work for a global health‑technology leader committed to improving access to quality healthcare.