CT Clinical Study Manager

As a Clinical Study Manager CT, you will be responsible for the execution and regulatory compliance of clinical studies for CT.

Your role:

• Participate in the handling of clinical studies, in compliance with all applicable regulations (such as ISO, GCP, and FDA) and Philips procedures, working under limited supervision.
• Ensure strict adherence to study protocols, regulatory standards, and Philips Processes/Procedures through meticulous execution of site assessment, on-site and remote monitoring and training, and close-out visits, proactively addressing deviations and ensuring data accuracy and study integrity.
• Work with study sites and investigators to provide support and guidance on protocol requirements, study procedures, and regulatory expectations.
• Act as a subject matter expert to provide guidance on GCP, ISO, and FDA regulatory requirements for the conduct of research involving human subjects in the medical device industry.
• Help review project documentation and deliverables for accuracy, completeness, and compliance with established protocols and regulatory requirements and GCP guidelines.
• Enhance study procedures and processes to optimize efficiency and data quality throughout the clinical research lifecycle and perform data review and verification activities to ensure accuracy and consistency of clinical trial data.
• Nurture and maintain relationships within the Clinical and Medical functions, as well as cross-functionally with Clinical Development, Biostatistics and Data Management, Regulatory, R&D, Quality, HEMAR, and other internal partners to achieve project objectives.
• Track study progress and performance against milestones, timelines, and budgetary constraints, conducting in-depth analysis of trends and deviations to inform proactive decision-making, risk mitigation strategies, and continuous improvement initiatives.
• Resolve queries, issues, and discrepancies related to study conduct, data collection, and regulatory compliance in a timely and effective manner.
• Support the development of study plans and protocols, integrating regulatory requirements, Good Clinical Practice (GCP) guidelines, and study objectives to ensure robust study design and execution.
• Utilize clinical trial applications including Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and Clinical Trial Management System (CTMS) with a high level of competency.
• Foster effective collaboration and communication across cross-functional teams and external collaborators, facilitating problem-solving, decision-making, and alignment on study objectives and priorities throughout the project lifecycle.
• Draft critical and timely study updates, findings, and recommendations to study leadership and senior management, demonstrating comprehensive understanding and analysis of study progress, challenges, and opportunities.

You're the right fit if:

• You hold a Bachelor’s or Master’s degree in Life Sciences or an equivalent field.
• You have 3–5 years of experience in clinical research execution in the medical device industry.
• You possess profound knowledge of clinical research process legislation and ICH-GCP guidelines. Experience using EDC, CTMS, and eTMF systems will be highly preferred.
• You demonstrate strong analytical, project management, and communication skills, thrive in cross-functional environments, and are committed to maintaining high standards of data integrity and regulatory compliance.
• Willingness to travel to our clinical study sites across the globe.

How we work together:

We believe that we are better together than apart. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

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 the lives of others.