Clinical Affairs: Clinical Project Manager
Core
Plan, prepare, and execute high-quality large-scale and/or complex clinical programs for medical devices, leading the clinical project team to complete deliverables within agreed timelines.
Role type
Senior Clinical Project Manager
Builds
Global clinical trials and associated project deliverables
Domain
Medical Devices / Clinical Research
Required skills
Clinical trial management, project leadership, cross-functional collaboration, risk identification and mitigation, budget and timeline management, regulatory compliance knowledge, protocol and study report writing, adverse event oversight, supply chain coordination
Preferred skills
Masters-level degree in clinical trial management or medicine, experience with complex global trials, background in science/health related fields
Technologies
Clinical trial management systems, project management tools
Responsibilities
Lead clinical project team members toward completion of deliverables; ensure trials are audit ready; manage programs within approved budgets and timelines; write clinical project deliverables such as protocols and final study reports; direct forecasting of devices necessary for projects; provide oversight of individual clinical trials to ensure safety concerns and adverse events are identified and addressed; identify project risks and implement mitigations; develop and implement corrective action plans at individual sites and across trials; coach others in the application of clinical research conduct, laws, regulations, and standards.
Seniority
Senior, hands-on IC with leadership responsibilities