Clinical Development Scientist (Cambridge, MA)
Your role:
- Provide strategic guidance on the design and development of clinical study protocols, including retrospective and prospective data collection methodologies
- Support the design and execution of key elements of the Clinical Development Plan and associated data collection activities, within the Hospital Patient Monitoring business group
- Defining clinical questions, study end-points, identifying relevant evidence, critically apprising evidence, and applying evidence to substantiate clinical and medical device claims
- Identify innovative methods to improve efficiency of collecting evidence and assessing risk of bias
- Collaborate on, or lead where appropriate, calls with regulatory agencies (FDA, EMA) to support clinical trial regulatory submissions
- Liaise with other functions to enable quality clinical study executionas the study design subject matter expert
- Collaborate with the clinical study team in site identification and selection, and provide assistance with study start-up activities
- Participate in Investigator meeting planning and execution and/or on-site initiation meetings
- Support CRAs/CROs on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures. Engage with investigators, site staff, CROs, and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies.
- Contribute to statistical methodologies to validate study objectives
You're the right fit if:
- Scientific degree (BS, M.S., MPH, Ph.D., or similar degree)in the health sciences, life sciences, clinical sciences or biomedical engineering, with experience in cardiology and hemodynamic monitoring
- 2+ years of experience in the design and execution of clinical or medical device studies, including retrospective and prospective designs
- Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation
- Experience and skill performing systematic medical/ scientific literature searches (PubMed, Google Scholar, etc.)
- Project/timeline management skills and organizational skills
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .
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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 commitment to diversity and inclusion .
consider candidates who require sponsorship for a work-authorized visa, now or in the future.