Clinical Study Manager

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About the role

Job Title Clinical Study Manager Job Description Clinical Study Manager, Sleep & Respiratory Care   The Clinical Study Manager oversees the execution and regulatory compliance of clinical studies, managing documentation, negotiations, and team priorities to ensure program objectives are met. The role maintains alignment with Philips standards, provides updates to senior management, and ensures readiness for audits. Your role: • Conducts and oversees all aspects of clinical studies, ensuring strict compliance with regulatory standards (ISO, GCP, FDA) and Philips procedures, including site assessments, monitoring, training, and close-out activities. • Serves as a key resource and subject matter expert for study sites and investigators, offering guidance on protocol requirements, study procedures, and regulatory expectations, while reviewing project documentation for accuracy and compliance. • Optimizes study efficiency and data quality through process improvements, thorough data review, and verification, leveraging clinical trial technologies such as EDC, eTMF, and CTMS proficiently. • Collaborates and builds effective relationships across Clinical, Medical, Biostatistics, Data Management, Regulatory, Quality, R&D, and other internal teams to achieve project goals and ensure seamless study execution. • Monitors study progress against milestones, timelines, and budgets; proactively identifies risks, resolves issues, and drives continuous improvement initiatives to ensure regulatory compliance and data integrity. You're the right fit if: ·       You’ve acquired 5+ years of experience in execution of clinical research in the medical device industry (preferred), pharma, biotech, academia, or government research required.   ·       Your skills include 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.). ·       You have a Doctorate degree or higher in a related field preferred, bachelor's masters degree required. ·       You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position . ·       You have strong attention to detail, have a learner mindset, and are coachable. Up to 10% travel required based on business needs. You must be based in the local Pittsburgh, PA area for proximity to study site locations.   How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.   This is a field-based role, requiring candidates to be local to Pittsburgh, PA.   About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.   • Learn more about our business . • Discover our rich and exciting history. • Learn more about our purpose. • Learn more about our culture.   Philips Transparency Details   The pay range for this position in PA is $102,000 to $162,000.   The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.      In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be off

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