Clinical Project Manager Medical Devices (m/f/d)
Core
Managing and overseeing local and international clinical trials for investigational medicinal products and medical devices.
Role type
Senior Clinical Project Manager
Builds
Clinical study protocols, reports, plans, informed consent forms, and risk management processes for medical device trials.
Domain
Medical Devices / Aesthetic Medicine
Deliverable
client delivery
Required skills
Clinical trial management, regulatory compliance (ICH-GCP, ISO 14155, MDR, FDA, EU-CTR), vendor selection and oversight, cross-functional team leadership, project management tools (MS Project), IVRS and EDC systems, risk management, process improvement.
Preferred skills
Experience in different medical indications and study designs, experience leading interdisciplinary international teams, knowledge of quality audits and CAPA management.
Technologies
MS Project, IVRS, EDC, Microsoft Office applications
Responsibilities
Manage and oversee local and international clinical trials; lead internal and clinical cross-functional sub-teams; prepare and review key clinical study documents; create and oversee study specific risk management processes; provide study status reporting; select and assist with qualifications of clinical trial vendors; ensure adherence to internal SOPs and regulatory requirements; support quality audits and manage CAPAs; support improvement of internal processes.
Seniority
Senior, hands-on IC
