Skills
• 18+ years Medical Device, IVD and Pharma clinical research experience
• Safety Officer, Global SAE reporting and periodic safety reporting, Clinical Event Committee management
• Building and managing Medical Device Safety Departments
• Trainer on EU / US medical device safety regulations and reporting practice
• Strong clinical / medical background – 12 years as Intensive Care / Anesthesia Nurse
• Excellent Medical-Scientific knowledge and hands on Medical Device experience in Cath Lab and OR.
• Scientific writing, Protocol, CSR and ICF writing, literature research experience
• Managing and overseeing all aspects of clinical trial projects from early planning, site selection to study report writing.
• +10 years of experience in leading global cross functional teams incl. Safety, QM, Regulatory, Project Management, Data Management, Monitoring
• First in man, phase II – IV, FIM/EFS, pre-CE, CE-mark, IDE and PMS trials with up to 200 sites / 2400 subjects globally incl. EU, US, South America, Japan and China.
• Clinical and Reimbursement strategy development, expanding indications
• Study planning, budget responsibility, CRO selection, developing PMS/PMCF strategies and monitoring/RBM concepts
• Heavy QM support, SOP writing, CAPA process, Risk management, ISO 9001 certification handling, ISO 14971 trained
• BD and Marketing support, deep involvement in strategy, client meetings, budgeting, preferred provider relationship development.
• Internal and clinical site trainer, medical / scientific liaison, congress speaker
• Safety Officer, Global SAE reporting and periodic safety reporting, Clinical Event Committee management
• Building and managing Medical Device Safety Departments
• Trainer on EU / US medical device safety regulations and reporting practice
• Strong clinical / medical background – 12 years as Intensive Care / Anesthesia Nurse
• Excellent Medical-Scientific knowledge and hands on Medical Device experience in Cath Lab and OR.
• Scientific writing, Protocol, CSR and ICF writing, literature research experience
• Managing and overseeing all aspects of clinical trial projects from early planning, site selection to study report writing.
• +10 years of experience in leading global cross functional teams incl. Safety, QM, Regulatory, Project Management, Data Management, Monitoring
• First in man, phase II – IV, FIM/EFS, pre-CE, CE-mark, IDE and PMS trials with up to 200 sites / 2400 subjects globally incl. EU, US, South America, Japan and China.
• Clinical and Reimbursement strategy development, expanding indications
• Study planning, budget responsibility, CRO selection, developing PMS/PMCF strategies and monitoring/RBM concepts
• Heavy QM support, SOP writing, CAPA process, Risk management, ISO 9001 certification handling, ISO 14971 trained
• BD and Marketing support, deep involvement in strategy, client meetings, budgeting, preferred provider relationship development.
• Internal and clinical site trainer, medical / scientific liaison, congress speaker
Projekthistorie
Reisebereitschaft
Verfügbar in den Ländern
Deutschland, Österreich und Schweiz
Ich suche Remote-Projekte
Heidelberg
DE
Heidelberg
DE
