Largeton Group · 2 days ago
Clinical Development Scientist
Cambridge, MA
Full-time
Onsite
Entry, Mid Level
2+ years expLargeton Group is seeking a Clinical Development Scientist to support the design, execution, and regulatory submission of clinical studies for hospital monitoring devices. The role involves providing strategic guidance on clinical study protocols, collaborating with regulatory agencies, and managing project timelines to ensure compliance and effectiveness.
ConsultingInformation TechnologyTraining
Responsibilities
Provide strategic guidance on clinical study protocol design (retrospective and prospective)
Develop and implement clinical development plans and data collection activities
Define clinical questions, endpoints, and identify/appraise evidence to substantiate device claims
Identify innovative and efficient methods for evidence collection and risk of bias assessment
Collaborate with regulatory agencies (FDA/EMA) to support clinical trial submissions
Serve as study design subject matter expert; liaise with cross-functional teams for study execution
Assist with site identification, selection, and study start-up activities
Participate in investigator meetings and on-site study initiations
Act as internal Principal Investigator on Philips-sponsored studies as needed
Support and advise CRAs/CROs on study protocols and procedures
Engage with investigators, site staff, CROs, and monitors to support study enrollment
Contribute to statistical methodologies and validation of study objectives
Assist with authoring manuscripts, conference presentations, and other dissemination activities
Review and synthesize scientific literature and competitive intelligence
Manage project timelines and ensure milestones are met
Maintain in-depth knowledge of competitor devices and relevant clinical/market developments
Ensure compliance with Good Documentation Practices, SOPs, GCP, and regulatory guidelines
Up to 20% travel required (regional/international)
Qualification
Required
Advanced degree (M.S., MPH, Ph.D., or similar) in health/life/clinical sciences or biomedical engineering
2+ years' experience designing/executing clinical or medical device studies
Knowledge of clinical research methodology, statistics, data analysis, and interpretation
Experience with systematic scientific literature searches (e.g., PubMed, Google Scholar)
Excellent written and verbal communication skills (English)
Strong project/timeline management, organization, and prioritization skills
Ability to work independently and as part of a (virtual) team
Proficiency with Microsoft Office
Preferred
Experience with EN ISO 14155 (Clinical Investigations) and ISO 14971 (Risk Management)
Prior experience with patient monitoring devices
Familiarity with medical device regulations and standards
Company
Largeton Group
Largeton Group is a delivery engine for large staffing firms.
51-200 employees
H1B Sponsorship
Largeton Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (10)
2023 (8)
2022 (6)
2021 (7)
2020 (11)
Funding
Current Stage
Growth StageLeadership Team
Ashutosh Tripathi
Managing Partner
Saurabh Prakash
Client Partnership Manager.
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