Beschreibung

In this role, you will provide essential medical oversight for clinical trials, ensuring compliance with protocols and safety assessments. You will collaborate with various teams, support regulatory processes, and contribute to the interpretation of clinical data, all while working in a dynamic environment.

Anforderungen

• •MD PhD in Biomedical Sciences or related field
• •Prior experience as a Medical Monitor
• •Experience in oncology and cell therapy
• •High degree of independent working
• •Attention to detail
• •Problem solving skills
• •Very good communication skills in English
• •German language skills are a plus

Aufgaben

• •Provide medical oversight for clinical trials from Phase 1 to Phase 3
• •Assess (Serious) Adverse Events for causality, expectedness, and clinical management
• •Serve as the primary contact for medical investigator inquiries
• •Review safety data documents and related materials
• •Lead and support medical data review meetings and DSMB meetings
• •Collaborate with Drug Safety on signal detection
• •Provide medical input on trial design and protocol development
• •Review and approve electronic Case Report Forms (eCRFs)
• •Contribute to Investigator Brochures
• •Ensure compliance with eligibility criteria and safety assessments
• •Participate in protocol deviation assessments
• •Support investigators with protocol-related questions
• •Participate in site selection and training activities
• •Contribute to Investigator Meetings and site visits as needed
• •Support regulatory filings and respond to regulatory inquiries
• •Provide medical expertise for Risk Management Plans
• •Ensure timely medical review of safety and efficacy data
• •Review patient narratives
• •Contribute to data interpretation in early clinical trials
• •Assist in clinical study reports, publications, and presentations

Benefits