Beschreibung

As a Medical Monitor, you will play a crucial role in ensuring the safety and integrity of clinical trials. Your daily activities will involve reviewing adverse events, collaborating with study teams, and providing medical expertise to uphold regulatory compliance and patient safety.

Anforderungen

• •Medical degree
• •Clinical experience in a hospital setting
• •Previous medical research experience in CRO, Pharma, Hospital, or with a regulatory body
• •Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials
• •Ability to interpret clinical trial data and assess safety trends
• •Knowledge of clinical research methodologies and statistical concepts
• •Ability to review and interpret clinical data and study reports
• •Experience of scientific writing
• •Knowledge of clinical trial medical monitoring and patient safety oversight
• •Experience with adverse event evaluation and safety reporting
• •Experience with regulatory requirements and documentation
• •Fluency in English
• •Strong communication and collaboration skills
• •Analytical and critical thinking skills
• •Detail-oriented and organized
• •Problem-solving mindset
• •Adaptability and flexibility in a dynamic environment

Aufgaben

• •Provide medical monitoring for clinical trials
• •Review and assess adverse events (AEs) and serious adverse events (SAEs)
• •Ensure timely reporting of suspected unexpected serious adverse reactions (SUSARs)
• •Serve as the primary medical contact for clinical sites and investigators
• •Address protocol-related questions and safety concerns
• •Ensure adherence to Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines
• •Participate in study start-up activities, including protocol development and investigator meetings
• •Support regulatory submissions
• •Assist in the preparation and review of Clinical Study Reports (CSRs)
• •Provide medical input during study design and risk assessment
• •Contribute to the development of investigator brochures and informed consent forms
• •Create study-specific training materials
• •Review and interpret clinical trial data for accuracy and relevance
• •Collaborate with investigators, sponsors, and clinical operations teams
• •Participate in safety review meetings and data monitoring committees (DMCs)
• •Provide medical information to clinical research teams
• •Identify and mitigate potential medical risks in clinical trials
• •Support audit and inspection readiness
• •Contribute to process improvement initiatives for medical monitoring workflows