Job Overview
The Clinical Development Lead will primarily focus on study design strategy for the development of clinical study protocols and support the clinical operations team with study execution. This person will apply epidemiology principles and methods to the clinical setting to support evidence generation across the Hospital Patient Monitoring businesses, particularly for cardiovascular and hemodynamic monitoring devices.
Essential Responsibilities and Duties
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 execution as 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
Serve as internal Principal Investigator on Philips sponsored studies where needed 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
Contribute to authoring of manuscripts, conference presentations, and other dissemination activities Review and synthesize scientific literature and competitive intelligence to support study and program strategy
Manage timelines and communication to ensure deliverables and milestones are met.
Acquire or possess in-depth knowledge of competitor devices, state-of-the-art, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
Comply with Good Documentation Practices to ensure quality and accuracy of document content and format
Ensure compliance with corporate (e.g. SOPs) and regulatory requirements (e.g. Google Cloud Platform and US and OUS guidelines).
Position Type/Expected Hours of Work This is a full-time position requiring up to 20% travel regionally and internationally.
Qualifications
Advanced scientific degree (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.)
Ability to clearly communicate to internal and external stakeholders orally and in writing, including management, academicians, clinicians, and scientists
Excellent English written and oral communications skills-- strong attention to detail related to consistency, grammar, syntax, and accuracy
Demonstrated ability to work in a (virtual) team environment, including leading discussions and presenting to internal business and regulatory stakeholders
Project/timeline management skills and organizational skills
Ability to prioritize and manage multiple projects and adapt to change as needed
Self-starter attitude with ability to learn quickly and self-educate on different medical device products and procedures; ability to work independently with minimal supervision
Strong familiarity with Microsoft Office
Knowledge and experience with EN ISO 14155 Clinical Investigations is a plus
Knowledge and experience with ISO14971 Risk Management is a plus
Prior knowledge and experience with patient monitoring devices is a plus
Knowledge in medical device regulation and standards is a plus
Additional Details
Minimum required qualifications : Minimum required Education: Bachelor's/ Master's Degree in Life Science or equivalent. Minimum required Experience: Minimum 2 years of experience with Bachelor's in areas such as Clinical Research, MedTech, Healthcare Administration or equivalent OR no prior experience required with Master's Degree. Minimum required
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