Clinical Study Manager

Job Description

As a Clinical Study Manager, you will be responsible for the execution and regulatory compliance of clinical studies for MO Ambulatory Monitoring Diagnostic systems.

Your role:

• Participating in the handling of clinical studies, in compliance with all applicable regulations (like ISO, GCP, and FDA) and Philips procedures, working under limited supervision.
• Ensuring strict adherence to study protocols, regulatory standards, and Philips processes through comprehensive site assessments, on-site and remote monitoring, and training activities.
• Collaborating with study sites and investigators to provide guidance on protocol requirements, study procedures, and regulatory expectations.
• Acting as a subject matter expert to provide guidance on GCP, ISO, and FDA requirements for human subject research within the medical device industry.
• Reviewing project documentation and deliverables for accuracy, completeness, and compliance with established protocols, regulatory requirements, and GCP guidelines.
• Enhancing study procedures and processes to optimize operational efficiency and data quality throughout the clinical research lifecycle.
• Conducting data review and verification to ensure the accuracy, consistency, and completeness of clinical trial data.
• Building and maintaining strong partnerships across Clinical Development, Biostatistics, Data Management, Regulatory, R&D, Quality, HEMAR, and other internal teams to achieve project objectives.
• Tracking study progress and performance against milestones, timelines, and budgets, identifying trends, risks, and deviations, and driving proactive mitigation strategies.
• Managing and resolving study-related queries, issues, and discrepancies in a timely and effective manner.
• Supporting the development of study plans and protocols that integrate regulatory requirements, GCP guidelines, and study objectives to ensure robust study design and execution.
• Utilizing clinical trial systems such as Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and Clinical Trial Management System (CTMS) effectively and efficiently.
• Fostering effective collaboration and communication across internal teams and external partners to ensure alignment on study objectives and priorities.
• Drafting 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 or pharmaceutical 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.

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.