Medical Data Reviewer (Client dedicated)

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:

• Serve as a Medical Data Reviewer and identify any errors in data by performing data review that require further clarification with the study sites
• Perform ongoing review of clinical/medical aspects of assigned patient data and documents
• Communicates any data training needs for CRAs, sites, etc
• Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)
• Provide clinical data Project Management and viewed as an expert in data clinical/medical review and cleaning.
• Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation
• May assist in review and contribute to data capture requirements guidance in line with protocol and reporting requirements.
• May be closely involved in data review and identification of readiness for clinical narratives for CSRs
• May participate in clinical data review meetings such as:

o Protocol Deviation review

o Data Review and Quality Team (DRQT)

o Statistical Review of Clinical Data (SRCD)

o Safety Monitoring Team (SMT) review

o Slide preparation of top-line results

You are:

• Educational Qualification: MBBS and MD degrees are mandatory (BHMS is not accepted)

• Minimum of 5 years' experience in clinical and medical data review within the pharmaceutical industry; 8+ years preferred, with demonstrated expertise in clinical data cross-checks and quality oversight.

• Prior experience in solid tumor oncology therapeutic area is highly desirable.

• Proficient in the use of clinical data tools and platforms, including Medidata, JReview, and MS Excel.

• Strong knowledge of clinical coding standards, with experience in coding review and query management; prior training in query writing is an asset.

• Demonstrated ability to navigate and manage clinical databases efficiently.

• Solid understanding of Good Clinical Practice (GCP), clinical trial design principles, and the broader drug development lifecycle.
• Exceptional written and verbal communication skills in English; proven ability to manage timelines, prioritize tasks, and operate effectively in cross-functional, fast-paced environments.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.