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.

What you will be doing:

• 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.

• 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

• Reviews Edit Check Plan for appropriate manual and automated 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 the stakeholders within the project team.

• Participates in or attends internal and client meetings as needed.

• Solves technical problems

• 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.

• Documenting Medical Data Review as per SOP.

• 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 (immuno-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

• Must work East coast hours

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.

Visit our careers site to read more about the benefits ICON offers.

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.

Are you a current ICON Employee? Please click here to apply