CT Clinical Study Manager

As a Clinical Study Manager for CT, you will be responsible for the execution and regulatory compliance of clinical studies, ensuring strict adherence to protocols, regulatory standards, and Philips procedures. This involves meticulous site assessment, monitoring, and training, proactively addressing deviations, and ensuring data accuracy. You will provide guidance on GCP, ISO, and FDA requirements, review project documentation, and optimize study procedures. The role requires nurturing relationships with internal and external partners, tracking study progress, resolving discrepancies, and supporting protocol development. High competency in clinical trial applications like EDC, eTMF, and CTMS is essential, along with strong collaboration and communication skills.

Must Have

• Execute and ensure regulatory compliance of clinical studies for CT.
• Ensure strict adherence to study protocols, regulatory standards, and Philips procedures.
• Work with study sites and investigators to provide support and guidance.
• Act as a subject matter expert on GCP, ISO, and FDA regulatory requirements.
• Review project documentation and deliverables for accuracy and compliance.
• Track study progress and performance against milestones, timelines, and budgetary constraints.
• Resolve queries, issues, and discrepancies related to study conduct and data.
• Support the development of study plans and protocols.
• Utilize Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and Clinical Trial Management System (CTMS) with high competency.
• Foster effective collaboration and communication with cross-functional teams.
• Draft critical and timely study updates, findings, and recommendations.
• Hold a Bachelor’s or Master’s degree in Life Sciences or an equivalent field.
• Have 3–5 years of experience in clinical research execution in the medical device industry.
• Possess profound knowledge of clinical research process legislation and ICH-GCP guidelines.
• Demonstrate strong analytical, project management, and communication skills.
• Be committed to maintaining high standards of data integrity and regulatory compliance.
• Willingness to travel to clinical study sites across the globe.

Good to Have

• Experience using EDC, CTMS, and eTMF systems is highly preferred.

1. Job title:

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

2. Your role:

• Participates in the handling of clinical studies, in compliance to all applicable regulations (like ISO, GCP and FDA) and Philips procedures, working under limited supervision.
• Ensures 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.
• Works with study sites and investigators to provide support and guidance on protocol requirements, study procedures, and regulatory expectations.
• Acts as a subject matter expert to provide guidance on GCP, ISO and FDA regulatory requirements for the conduct of research involving human subjects is required in the medical device industry.
• Helps to review project documentation and deliverables for accuracy, completeness, and compliance with established protocols and regulatory requirements and GCP guidelines.
• Enhances study procedures and processes to optimize efficiency and data quality throughout the clinical research lifecycle and performs data review and verification activities to ensure accuracy and consistency of clinical trial data.
• Nurtures and maintains relationships within the Clinical and Medical functions, as well as cross-functionally with Clinical Development, Biostatistics and Data Managements, Regulatory, R&D, Quality and HEMAR and other internal partners to achieve project objectives.
• Tracks 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.
• Resolves queries, issues, and discrepancies related to study conduct, data collection, and regulatory compliance in a timely and effective manner.
• Supports 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.
• Utilizes clinical trial applications including Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and Clinical Trial Management System (CTMS) with high level of competency.
• Fosters effective collaboration and communication with across cross-functional teams and external collaborators, facilitating problem-solving, decision-making, and alignment on study objectives and priorities throughout the project lifecycle.
• Drafts 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.

3. 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

4. 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.

Role type: Field

About Philips

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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.

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