Medical Data Reviewer

🕒 May 26

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Reviews listings / data visualisation tools / patient profiles with medical data for medical plausibility and consistency. • Supports creation of the Medical Data Review Plan according to standards. • Assures MDRP consistency with other project plans contracted scope of work, and SOPs and procedures • Reviews Edit Check Plan for appropriate medical edit checks and consolidates all medical data review checks. • Coordinates project-specific tasks such as review of the electronic Case Report Form (eCRF) and CRF Completion Guidelines. • Reviews and approves all test outputs of listings / visualisations in collaboration with stakeholders within the project team. • Participates in or attends internal and client meetings as needed. • Reviews data for protocol deviations. • Reviews and responds to Quality Control (QC) findings as needed • Ensures that medical data review activities are completed within the agreed timelines and meet defined quality standards. • Utilizes therapeutic area expertise to review clinical data, identify discrepancies, and raise and respond to medical queries.

🎯 Requirements

• Educational scientific background such as MD, PharmD, PhD, Nursing degree, MS • ≥ 5 years of pharmaceutical clinical/medical data review experience is required, including clinical crosscheck experience. • 8+ years is preferable • Experience with Solid Tumor Oncology • Excellent verbal and writing communication in English • Strong operational skills and demonstrated ability to meet timelines. • Experience in coding review • Query writing training • Strong clinical database navigation skills • Strong MS Excel • Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process

🏖️ 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