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Medical Data Reviewer

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

What You Will Be Doing:

1. Reviews listings / data visualisation tools / patient profiles with medical data (vital signs, lab data, medical history, concomitant medication, adverse events etc.) for medical plausibility and consistency.
2. Supports creation of the Medical Data Review Plan according to standards. Assures MDRP consistency with other project plans( i.e. Data Management Plan, Edit Check Plan, Data Transfer Plan), contracted scope of work, and SOPs and procedures
3. Reviews Edit Check Plan for appropriate manual and automated medical edit checks and consolidates all medical data review checks.
4. Coordinates project-specific tasks such as review of the electronic Case Report Form (eCRF) and CRF Completion Guidelines.
5. Reviews and approves all test outputs of listings / visualisations in collaboration with the stakeholders within the project team.
6. Participates in or attends internal and client meetings as needed.
7. Solves technical problems
8. Reviews data for protocol deviations.
9. Reviews and responds to Quality Control (QC) findings as needed
10. Ensures that medical data review activities are completed within the agreed timelines and meet defined quality standards.
11. Documenting Medical Data Review as per SOP.
12. Utilizes therapeutic area expertise (e.g. knowledge of RECIST and CTCAE grading on oncology trials) to review clinical data, identify discrepancies, raise and respond to medical queries following through until query resolution.

You are:

• 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 preferrable
• Experience with Solid Tumor Oncology
• Excellent verbal and writing communication in English, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
• Experience in coding review
• Query writing training
• Strong clinical database navigation skills
• Strong MS excel, project management
• Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• 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.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.