Medical Monitor

Job summary

The Medical Monitor ensures the medical and scientific integrity of clinical trials while overseeing patient safety and regulatory compliance. They collaborate with sponsors, investigators, and clinical teams to manage study protocols, adverse events, and risk mitigation throughout the trial lifecycle.

Job details

🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you. Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description Summary Job Description THE MEDICAL MONITOR ROLE 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. Reporting to the Vice President of Clinical Operations (EU), the Medical Monitor works closely with sponsors, investigators, and internal clinical teams to ensure the highest ethical, medical, and regulatory standards throughout the clinical trial lifecycle. The role requires expertise in clinical trial design, medical data interpretation, and regulatory compliance, with a strong focus on patient safety, risk mitigation, and adherence to study protocols. ESSENTIAL JOB FUNCTIONS Medical Oversight & Patient Safety: 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. Clinical Trial Conduct & Compliance: Help ensure 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. Medical & Scientific Expertise: 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. Stakeholder Engagement & Communication: 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 information to clinical research teams, ensuring alignment on trial protocols and safety procedures. Risk Management & Continuous Improvement: 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. PREPARATION, KNOWLEDGE, SKILLS & ABILITIES Medical degree. Clinical experience in a hospital setting. Previous Medical Research experience(e.g., 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, assess safety trends, and make informed medical decisions. Technical competencies: Knowledge of clinical research methodologies, study design, and statistical concepts. Ability to review and interpret clinical data, protocols, and study reports. Experience of scientific writing Knowledge of clinical trial medical monitoring and patient safety oversight. Experience with adverse event and serious adverse event evaluation and safety reporting. Experience with regulatory requirements and regulatory documentation. Fluent in English. Soft Skills: Strong communication and collaboration skills with cross-functional teams. Analytical and critical thinking to assess and interpret clinical data effectively. Detail-oriented and organized, ensuring accuracy in safety reporting and documentation. Problem-solving mindset, able to address challenges in clinical trial execution. Adaptability and flexibility to work in a dynamic, fast-paced environment. WORKING CONDITIONS/PHYSICAL DEMANDS Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting up to 30 lbs. Languages English Education Bachelor of Science (BS): Medicine Contract Type Regular Salary Range The final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope. 120.000,00 USD Minimum - 250.000,00 USD Maximum

What you’ll do

The Medical Monitor ensures the medical and scientific integrity of clinical trials while overseeing patient safety and regulatory compliance. They collaborate with sponsors, investigators, and clinical teams to manage study protocols, adverse events, and risk mitigation throughout the trial lifecycle.

Requirements

Candidates must hold a medical degree and possess significant experience in clinical research within a CRO, pharmaceutical, or hospital setting. Proficiency in GCP, ICH guidelines, and clinical data interpretation is essential for this role.

Listed skills

• Regulatory Compliance · Preferred
• Google Cloud · Preferred
• Clinical Operations · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Medical monitoring
• Clinical trial design
• Patient safety
• Regulatory compliance
• GCP
• ICH guidelines
• Adverse event evaluation
• Scientific writing
• Risk mitigation
• Data interpretation
• Protocol development
• Clinical operations
• Stakeholder engagement
• Regulatory documentation
• Statistical concepts
• Informed Consent
• Regulatory Documents
• Courage
• Data Interpretation
• Clinical Experience
• Workflow Management
• Data Monitoring
• Ethical Standards And Conduct
• Safety Procedures
• Medical Monitoring
• Risk Mitigation
• Adaptability
• Auditing
• Medical Research
• Clinical Research
• Clinical Trials
• Clinical Study Design
• Clinical Study Reports
• Communication
• Regulatory Compliance
• Continuous Improvement Process
• Critical Thinking
• English Language
• Patient Safety
• Good Clinical Practices (GCP)
• Innovation
• Problem Solving
• Risk Management
• Operations
• Pharmaceuticals
• Regulatory Requirements
• Risk Analysis
• Scientific Methods
• Scientific Writing
• Stakeholder Engagement

Job areas

• Healthcare
• Science & Research
• Consulting
• Medical Monitor
• Clinical Investigator
• Research and Development Managers
• Clinical Research Coordinators
• Natural Sciences Managers

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