Clinical Study Manager

Job Title

Job Description

1. Job title:

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

2. Your role:

• Participating in the handling of clinical studies in compliance to 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.

3. Youre the right fit if:

• You hold a Bachelors or Masters degree in Life Sciences or an equivalent field.
• You have 35 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.

4. How we work together:

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

Role type: Field

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If youre 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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