CT Clinical Study Manager at Philips

Best, North Brabant, Netherlands -

Full Time

Start Date

Immediate

Expiry Date

25 Mar, 26

Salary

0.0

Posted On

25 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Regulatory Compliance, Project Management, Data Integrity, GCP Guidelines, ISO Standards, FDA Regulations, Data Review, Cross-Functional Collaboration, Problem-Solving, Communication Skills, Analytical Skills, EDC Systems, CTMS Systems, eTMF Systems, Study Protocols

Industry

Hospitals and Health Care

Description

Job Title CT Clinical Study Manager Job Description 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 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. • Learn more about our business. • Discover our rich and exciting history. • Learn more about our purpose. 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. #LI-EU At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights

Responsibilities

The Clinical Study Manager is responsible for the execution and regulatory compliance of clinical studies, ensuring adherence to protocols and regulatory standards. This role involves monitoring study progress, addressing deviations, and collaborating with study sites and investigators.