Clinical Study Manager

Philips

3d•$102,000 - $182,000•Onsite

About The Position

The Clinical Study Manager for Sleep & Respiratory Care 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.

Requirements

5+ years of experience in execution of clinical research in the medical device industry (preferred), 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 preferred (ISO 13485, 14155, ICH/GCP guidelines, etc.).
Bachelor's degree or higher, master's preferred.
Strong attention to detail, learner mindset, and 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.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Nice To Haves

Experience in execution of clinical research in the medical device industry
Knowledge of medical device clinical trials design and best practices
Familiarity with relevant medical device standards (ISO 13485, 14155, ICH/GCP guidelines, etc.)
Master's degree

Responsibilities

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.