Clinical Development Scientist,IGT
Core
Analyzes clinical trial protocols and studies, crafts compliant Clinical Evaluation Reports (CERs) and Clinical Study Reports (CSRs), and develops Clinical Development and Market Access strategies for medical devices.
Role type
Senior IC clinical development scientist (medical devices)
Builds
Clinical protocols, CERs, CSRs, regulatory submissions, and market access strategies
Domain
Medical devices / Clinical development
Required skills
Clinical trial protocol analysis, Clinical Evaluation Report (CER) writing, Clinical Study Report (CSR) writing, Regulatory compliance, Clinical data analysis, Literature review, Key Opinion Leader (KOL) engagement, Strategic planning, Medical writing
Preferred skills
MD degree, Clinical experience in equipment or device R&D, Project management, Business acumen
Technologies
Standard clinical software tools and systems
Responsibilities
Analyze clinical trial protocols for regulatory adherence and strategic alignment; Craft comprehensive CERs, CSRs, and regulatory submission sections; Troubleshoot complex issues in clinical data collection, analysis, and reporting; Assess and synthesize clinical study data for publications and dissemination; Develop Clinical Development and Market Access strategies; Perform literature searches to support evidence generation for New Product Introduction (NPI) and Life Cycle Management (LCM); Support relationships with KOLs and Investigators; Present findings to internal stakeholders.
Seniority
Mid-level to Senior, hands-on IC