Clinical Project Lead
Core
Coordinate designated clinical study programs in the region for medical devices, managing feasibility, logistics, budget, and site compliance.
Role type
Senior Clinical Project Lead (Medical Devices)
Builds
Clinical trials and device studies for Abbott's medical device portfolio
Domain
Medical Devices / Clinical Research
Required skills
Clinical study coordination, Feasibility assessment, Protocol review, Investigator selection, CRO management, Ethics/Governance submissions, Regulatory documentation, Device logistics, Site qualification, Monitoring visits, Protocol compliance (ICH GCP/ISO 14155), Data collection (CRF), Contract negotiation, Budget management, CRA mentorship, SAE reporting, Study reporting
Preferred skills
Medical device industry experience, Pharmaceutical industry experience, TGA regulations knowledge, OH&S training
Technologies
Microsoft Office Suites (Word, Excel, PowerPoint)
Responsibilities
Coordinate clinical study programs, Assess feasibility and logistics of studies, Review study design and protocols, Identify and select investigators, Manage CROs, Prepare Ethics and Governance submissions, Collect regulatory documentation, Oversee device logistics, Arrange investigator meetings, Negotiate study budgets, Manage site payments, Order and distribute study supplies, Mentor CRAs, Conduct site qualification and monitoring visits, Ensure protocol and regulatory compliance, Collect data on case report forms, Organize investigator update meetings, Review FCRA reports, Liaise with Headquarters and country offices, Communicate with investigators and site staff, Prepare monthly tracking reports, Write and review study reports, Handle customer complaints
Seniority
Senior, hands-on IC
