Publié le mois dernier
Medical Monitor
@ Alira Health GmbH
Télétravail au Canada
En bref
Alira Health GmbH is hiring a full-time Medical Monitor to oversee patient safety and the medical and scientific integrity of clinical trials. The role reviews adverse events, serves as the primary medical contact for sites, and supports protocol execution and regulatory compliance. The posting states a salary range of 120,000 to 250,000 USD and a regular contract type.
Responsabilités :
- Medical monitoring and patient safety oversight for clinical trials
- Review of adverse events and serious adverse events
- Primary medical contact for sites and investigators
- Support for protocol development and regulatory submissions
- Review of clinical study reports and trial data
Résumé des exigences :
- Medical degree
- Hospital clinical experience
- Medical research experience in CRO, pharma, hospital or regulatory body
- Knowledge of GCP, ICH guidelines and regulatory requirements
- Scientific writing experience
- Fluent in English
Outils et compétences
Source et dates
Site carrière / système de candidatures · workday
- Date publiée par l’employeur
- 2026-10-11
- Première détection par notre source
- 2026-10-12
- Mise à jour du dossier source
- 2026-11-06
Ces dates décrivent le dossier source, pas une vérification en direct du recrutement. Consultez l’offre originale.
Détails du poste
| Niveau | Intermédiaire |
| Domaine | Médecins et pratique avancée |
| Heures par semaine | 40 (estimé) |
| Milieu de travail | Bureau |
| Position | Assis et debout |
| Exigences physiques | physique faible · soulever 30 lb · ordinateur élevé |
| Langues | English |
| Formation | Diplôme professionnel (médecine, droit…) (exigé) |
| Domaines d’études | Medicine |
Résumé et détails rédigés par l’IA à partir de l’offre; l’offre de l’employeur fait foi.
Alira Health GmbH
Profil d’entreprise sauvegardé
Renseignements historiques provenant d’un profil The Jobs API sauvegardé (champs LinkedIn/Crunchbase). Ils ne sont pas vérifiés en temps réel; les chiffres peuvent avoir changé. Les valeurs manquantes restent inconnues.
Trusted Advisor and CRO for Life Sciences Companies Globally
Description complète de l’entreprise
Alira Health is a global healthcare consultancy redefining evidence generation through patient partnerships. By uniting strategic consulting, CRO services, and technology, the company supports life sciences organizations in accelerating development, improving access, and delivering measurable outcomes across the product lifecycle.
- Abonnés LinkedIn
- 57 871
- Personnes associées sur LinkedIn
- 573
- Bureaux déclarés
- 1 Grant St, Framingham, Massachusetts 01702, US
- Anna-Sigmund Strasse 1-3, Munich, Germany 82061, DE
- Carrer d'aragó, 326, Principal Floor, Barcelona, Catalonia 08009, ES
- Via Germania, 2, Verona, Veneto 37136, IT
- Hochbergerstrasse 60f, Basel, BS 4057, CH
- Galleria Ugo Bassi, 1, Bologna, Emilia-Romagna 40121, IT
- 55, Rue La Boétie, Etage 1, Paris, France 75008, FR
- Via dell'unione, 1, Milan, Lombardy 20122, IT
- 30 Adelaide St E, Toronto, Ontario M5C 3G8, CA
- Zuidhaven 9, Zevenbergen, 4762PA, NL
- 3-6-1 Azuma-cho, Tokyo, 196-0033, JP
- Catégories d’activité
- Health Care
- Consulting
- Biotechnology
- Business consulting
- Management and consulting
- Autres noms enregistrés
- Alira Health
- Spécialités
- Nuclear medicine
- Rare disease
- Robotics
- CDMO medtech
- Value-based contracting
- Drug delivery systems
- Antibody–drug conjugates
- Biosimilars
- CDMO medtech
- CDMO biologics
- Autoimmune
- Wound care
- and Cell&gene
- Le profil indique une agence de recrutement
- Non
- Investissement total déclaré
- 233 000 000
La devise et la date d’observation ne sont pas fournies; ce n’est ni une valorisation actuelle ni une ronde de financement.
Alira Health is a global healthcare consultancy redefining evidence generation through patient partnerships. By uniting strategic consulting, CRO services, and technology, the company supports life sciences organizations in accelerating development, improving access, and delivering measurable outcomes across the product lifecycle.
| Champ | Valeur |
|---|---|
| Secteur | Pharmaceutical Manufacturing |
| Taille | 501-1,000 employees |
| Siège social | Framingham, Massachusetts |
| Type d’organisation | Privately Held |
| Spécialités | Nuclear medicineRare diseaseRoboticsCDMO medtechValue-based contractingDrug delivery systemsAntibody–drug conjugatesBiosimilarsCDMO medtechCDMO biologics |
| Offres sur Jobsy | 1 |
| Voir la page |
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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
EnglishEducation
Bachelor of Science (BS): MedicineContract Type
RegularSalary 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 MaximumJournal
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