Associate Analyst, Clinical Device Management
Core
Manage device accountability, trial workflow timelines, and regulatory reporting for clinical trials of transcatheter heart valves.
Role type
Associate Analyst, Clinical Device Management
Builds
Clinical trial evidence and regulatory submissions for Edwards' Transcatheter Heart Valve (THV) devices
Domain
Medical Devices / Cardiovascular / Clinical Trials
Required skills
Clinical trial management, Device accountability, Regulatory reporting, Data analysis, Process improvement, ERP systems, Salesforce, CTMS, Quality compliance
Preferred skills
JD Edwards, Investigational device accountability, Clinical trial master files (TMFs), Good Clinical Practices (GCP), Good Documentation Practices (GDP), eTMF management, MS Office Suite
Technologies
JD Edwards, Salesforce, CTMS, eTMF, MS Office Suite
Responsibilities
Investigate and analyze discrepancies between site and JDE data on device accountability; Provide training on device accountability process within electronic databases; Identify and implement process development solutions for trial workflow timelines; Compile and analyze dates for regulatory reports submission; Partner with Quality to resolve device-related issues; Communicate with sites and field teams to resolve queries.
Seniority
Junior, hands-on IC