Manage and coordinate clinical performance evaluations, including obtaining offers and awarding cooperation projects with external partners
Job Summary
Manage and coordinate clinical performance evaluations, including obtaining offers and awarding cooperation projects with external partners.
Prepare and review study documents, technical documentation, and country registration confirmations in compliance with national laws, guidelines, and regulations.
Communicate with authorities, ethics committees, key opinion leaders, consultants, CROs, and suppliers while managing budgets and invoices.
Matching Summary
Manage and coordinate clinical performance evaluations, including obtaining offers and awarding cooperation projects with external partners.
Skills & Requirements
Must-have
Clinical performance evaluations
Contact with authorities and ethics committee
Study documents preparation and review
Budget and investment planning
Communication with key opinion leaders
Good knowledge of MDR and IVDR
Good knowledge of FDA requirements
Nice-to-have
Independent and reliable work
Fast-paced and changing environment
Diplomacy and conflict resolution
Key Requirements
At least 3 years CPM or 5-6 years CRA experience
Life sciences degree or equivalent experience
ICH-GCP, ISO 14155, ISO 20916 knowledge
MDR and IVDR knowledge
FDA requirements, ISO regulations, CLSI guidelines knowledge