Medical Monitor @Alira Health GmbH

[Hiring] Medical Monitor @Alira Health GmbH

Mar 28, 2025 - Alira Health GmbH is hiring a remote Medical Monitor. 💸 Salary: unspecified. 📍Location: Germany.

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Role Description

The Medical Monitor is a key clinical expert responsible for ensuring the medical and scientific integrity of clinical trials, overseeing patient safety, and supporting study teams in protocol execution.

Provide medical monitoring for clinical trials, ensuring the safety and well-being of study participants.
Review and assess adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs), ensuring timely reporting and regulatory compliance.
Serve as the primary medical contact for clinical sites and investigators, addressing protocol-related questions and safety concerns.
Oversee study adherence to Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and local regulatory requirements.
Participate in study start-up activities, including protocol development, investigator meetings, and regulatory submissions.
Support the preparation and review of Clinical Study Reports (CSRs) and other regulatory documents.
Provide medical input during study design, protocol development, and risk assessment to ensure scientific rigor and feasibility.
Contribute to the development of investigator brochures, informed consent forms, and study-specific training materials.
Assist in the review and interpretation of clinical trial data, ensuring accuracy and relevance.
Collaborate with investigators, sponsors, clinical operations teams, and regulatory authorities to support study execution.
Participate in safety review meetings, data monitoring committees (DMCs), and investigator meetings.
Provide medical training to clinical research teams, ensuring alignment on trial protocols and safety procedures.
Identify and mitigate potential medical risks associated with clinical trial conduct.
Support audit and inspection readiness, ensuring trial compliance with regulatory expectations.
Contribute to process improvement initiatives, optimizing medical monitoring workflows and best practices.

Qualifications

Medical degree (MD) is required; specialization in a relevant therapeutic area (e.g., oncology, cardiology, neurology) is a plus.
Clinical experience and/or previous industry experience in medical monitoring or clinical research.
Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials.
Experience in safety monitoring, pharmacovigilance, or clinical risk management.
Ability to interpret clinical trial data, assess safety trends, and make informed medical decisions.
Prior experience in sponsor, CRO, or regulatory interactions is preferred.

Requirements

Clinical trial medical monitoring and patient safety oversight.
Adverse event and serious adverse event evaluation and reporting.
Knowledge of clinical research methodologies, study design, and statistical concepts.
Experience with regulatory requirements, pharmacovigilance, and safety reporting.
Ability to review and interpret clinical data, protocols, and study reports.
Proficiency in scientific writing and regulatory documentation.
Fluent in English; additional European languages (e.g., French, German, Italian) are a plus.

Benefits

Professional development opportunities.
Global travel.
Flexible work programs.

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📍	Be aware of the location restriction for this remote position: Germany
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Medical Monitor @Alira Health GmbH

All others

Salary 💸 unspecified	Remote Location Germany
Job Type full-time	Posted Mar 28, 2025

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📍	Be aware of the location restriction for this remote position: Germany
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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[Hiring] Medical Monitor @Alira Health GmbH

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