Medical Monitor

Alira Health; München; Vor Ort; EUR 60.000 - 75.000; Vollzeit

Zusammenfassung

Alira Health in Germany is seeking a Medical Monitor to ensure the medical and scientific integrity of clinical trials, oversee patient safety, and support study teams in protocol execution. 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.

Fluent in English, you will collaborate with sponsors, investigators, and internal teams to ensure ethical,

Qualifikationen

• Medical degree and clinical experience required.
• Knowledge of GCP, ICH guidelines and regulatory requirements.
• Ability to interpret trial data and assess safety trends.
• Strong written and oral communication in English.

Aufgaben

• Provide medical monitoring for clinical trials, ensuring patient safety.
• Review adverse events and SUSARs with timely regulatory reporting.
• Support study start-up activities and regulatory submissions.
• Contribute to trial design, CSR reviews and training materials.
• Collaborate with sponsors, investigators and cross‑functional teams.

Kenntnisse

Fluent in English

Medical decision making

Analytical thinking

Communication

Collaboration

Critical thinking

Regulatory knowledge

Ausbildung

Medical degree

Bachelor of Science (BS): Medicine

Jobbeschreibung

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.

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

Salary Range: euro 60.000 - 75.000

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. 60.000 - 75.000

Company

Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle. With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork. We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience.

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