Medical Data Reviewer

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

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

• 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

What ICON can offer you:

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

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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