As a Medical Monitor you will be responsible to provide therapeutic expertise as a consultant and for a variety of tasks, such as participation in DSMB meetings and pharmacovigilance discussions, providing assistance in interpretation of protocol, and with the possibility of participation on initiation and monitoring visits. The Medical Monitor is responsible for communicating the trends and integrates FAQs from across regions and countries; ensuring that all the activities are in compliance with study protocol and procedures, ICH-GCP guidelines and the applicable regulations and SOPs.

Job Description

• Provides therapeutic expertise as consultant for PM, CTL(s), CRA(s) and Investigators;
• Attends Global training of investigators;
• Communicates trends seen across regions or countries;
• Participates in interim analysis trainings, DSMB meetings, pharmacovigilance discussions if requested;
• Provides input for Final Study Report;
• Integrates FAQs from across regions or countries;
• Ensures safety and welfare of participating patients;
• CRF data medical review and query;
• Early recognition, identification, assessment and timely reporting of safety issues;
• Provides 24/7 therapeutic expert consultation support to the sites;
• Provides medical training for PMs, CTLs and CRAs;
• Provides training in study specific medical issues for Investigators;
• Provides assistance in interpretation of protocol;
• Participates on initiation and monitoring visits if requested by CTL or PM;
• Elaboration of Medical Monitoring- and Safety management Plans for clinical projects.

Requirements

• Medical degree;
• at least 2 years of experience in Medical Monitor position;
• at least 3 years of clinical practice and at least 5 years of experience in clinical research as CRA or CRM;
• Training in Medical Monitoring;
• Confident IT skills and knowledge of IT systems;
• Competency in written and spoken English.

What we can offer

• Attractive and competitive salary
• Semi-home office opportunity
• Cafeteria from the first whole month spent at the company
• Dedicated and supportive team
• Multinational environment
• Regular team buildings and company events