Medical Monitor*(m/w/x)

Beschreibung

You will drive clinical trial success by providing expert medical oversight and safety analysis. From protocol design to regulatory filings, you'll ensure patient safety and data integrity.

Anforderungen

• •Medical doctor degree
• •Prior experience as Medical Monitor
• •Experience in oncology and cell therapy
• •Experience in clinical development or trial oversight
• •High degree of independent working
• •Attention to detail
• •Problem solving skills
• •Very good English communication skills
• •German language skills as a plus

Aufgaben

• •Provide medical oversight for Phase 1 to 3 clinical trials
• •Assess adverse events for causality and clinical management
• •Review CIOMS and MedWatch safety forms
• •Serve as the primary contact for medical investigator inquiries
• •Review medical plans and safety data documents
• •Lead medical data review and DSMB meetings
• •Collaborate with Drug Safety on signal detection
• •Provide medical input for trial design and protocols
• •Review and approve electronic Case Report Forms
• •Develop content for Investigator Brochures
• •Ensure protocol compliance for dosing and safety assessments
• •Participate in protocol deviation assessments
• •Support site selection and staff training
• •Contribute to investigator meetings and site visits
• •Support regulatory filings and risk management plans
• •Perform medical reviews of safety and efficacy data
• •Review patient narratives and interpret clinical data
• •Contribute to study reports, publications, and presentations

Benefits