Immatics Biotechnologies GmbH
Medical Monitor*(m/w/x)
Full-time/Part-timeWith HomeofficeExperienced
Tübingen, München, Berlin
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ALAlira Health GmbH
Medical Monitor(m/w/x)
München
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Medical monitoring for clinical trials, assessing adverse events and ensuring SUSAR reporting. Medical degree and clinical hospital experience required. Direct contact for sites, addressing safety concerns.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Alira Health GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
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ALAlira Health GmbH
Medical Monitor(m/w/x)
München
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Medical monitoring for clinical trials, assessing adverse events and ensuring SUSAR reporting. Medical degree and clinical hospital experience required. Direct contact for sites, addressing safety concerns.
Requirements
- 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
Tasks
- 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
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Alira Health GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
- Immatics Biotechnologies GmbH
Medical Monitor*(m/w/x)
Full-time/Part-timeWith HomeofficeExperiencedTübingen, München, Berlin - Immatics Biotechnologies GmbH
Medical Monitor*(m/w/x)
Full-time/Part-timeWith HomeofficeExperiencedTübingen, München - PSI CRO
Central Monitoring Manager(m/w/x)
Full-timeWith HomeofficeExperiencedMünchen - PSI CRO
Senior / Clinical Research Associate(m/w/x)
Full-timeWith HomeofficeSeniorMünchen - Edwards Lifesciences
Senior Clinical Safety Specialist(m/w/x)
Full-timeWith HomeofficeSeniorMünchen