[Hiring] Medical Data Reviewer @ICON plc

Role Description

As a Senior Medical Data Reviewer at ICON, you will provide expert medical oversight of clinical trial data, ensuring accuracy, consistency, and patient safety. You will support complex programmes, mentor colleagues, and contribute to the development of robust medical review practices.

As a subject matter expert, the Medical Data Reviewer is responsible for ensuring high quality medical review of phase I-III clinical trial data in the field of oncology, neurology and immunology or other therapeutic areas of interest, in compliance with GCP/ICH and regulatory requirements.

• The Medical Data Reviewer works in close collaboration with the Medical Lead and/or Clinical Research Scientist to set up and coordinate the medical data review process.
• Assists with medical data review and manages medical queries.
• Ensures that the data is comprehensive from a medical point of view across different studies and projects.
• Supports database milestones (such as interim analysis, DMCs or Health Authority interactions), database and post lock activities.
• Facilitates resolution of clinical data issues.
• Conducts medical review of the data as per Medical Data Review Plan on incremental listings and patient profiles.
• Uses pre-established criteria to assure that patient data is complete and medically plausible.
• Clarifies inconsistencies and missing events.
• Reviews data for protocol deviations.
• Raises queries to the sites, follows them until resolution, and documents the medical review according to Medical Data Review Plan.

Qualifications

• More than 2 years’ experience in pharmaceutical industry or clinical research organization or health care experience, as a Medical Data Reviewer, Medical Monitor or similar roles.
• Basic knowledge in planning, executing, and reporting global clinical studies.
• Fundamental knowledge of GCP/ICH guidelines, clinical trial design, medical data review, statistics, regulatory processes, and drug development processes in oncology, neurology and/or immunology.
• Demonstrates knowledge and application of statistical analysis methodology.
• Proven analytical and organizational skills with a strong attention to detail.
• Good communication skills - verbal, written and listening.
• Educational and/or work experience in the respective therapeutic area (e.g. Oncology, Neurology and/or Immunology) preferred.
• Experience in analysis and interpretation of clinical data and a working knowledge of biostatistics, ICH-GCP, and regulatory requirements for clinical studies.
• Proficient English in written/verbal communication and presentation skills.
• Participates in internal and external relevant meetings, as needed.
• Experience in clinical databases, industry techniques and standards.
• Knowledge of patient profiles and data listings.
• Aptitude to interpret medical history and clinical information, including cancer diagnosis, treatment options and clinical safety and efficacy data (RECIST 1.1 assessment, CTCAE grading other relevant criteria).
• Collaborate with relevant functions to improve the quality of clinical data review/insights.
• Assist in the development and monitoring of the data review strategy.
• If applicable, may support writing patient narratives or uploading essential documents related to their task to the electronic Trial Master File.

Requirements

• Degree in a medical profession or life sciences (physician, nurse, pharmacist, scientist) is required. PhD, MBBS, BDS, MD strongly preferable.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Benefits

• Competitive base salary and performance related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.
• Benefits may vary depending on role and location.