Ecocareers · 2 days ago
Clinical Development Scientist
Cambridge, MA
Full-time
Onsite
Entry, Mid Level
2+ years expConfidential company is seeking a Clinical Development Scientist to lead the design and execution of clinical study protocols for cardiovascular and hemodynamic monitoring devices. The role involves providing strategic guidance, collaborating with regulatory agencies, and ensuring compliance with clinical study protocols and regulatory requirements.
Staffing & Recruiting
No H1B
Responsibilities
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 enrolment 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. GCP and US and OUS guidelines)
Qualification
Required
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
Knowledge in medical device regulation and standards
Knowledge and experience with EN ISO 14155 Clinical Investigations
Knowledge and experience with ISO14971 Risk Management
Prior knowledge and experience with patient monitoring devices
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
Candidate must have an active US Passport as there is travel, mostly domestic but some international
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase