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Medical Data Reviewer

3 weeks ago

Burlington, Ontario, Canada ICON plc Full time
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:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements

  • A range of health insurance offerings to suit you and your family's needs.

  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.

  • Life assurance

  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

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.

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 or submit a request here.

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.

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