At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touchpoint. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
About the Role
The Medical Data Reviewer (MDR), in close cooperation with the Medical Director (MD), sets up and coordinates the medical data review process, conducts medical data review and manages medical queries. The MDR role requires a close collaboration with various members of the biometrics team. Specifically, the MDR reviews medical data for medical plausibility and ensures that the data is comprehensive from a medical point of view across different studies and projects.
Key Responsibilities:
• Prepares listings with medical data (vital signs, lab data, medical history, concomitant medication, etc.) for medical review for plausibility.
• Under close supervision, coordinates and drafts the Medical Data Review Plan (MDRP) according to ICON standards, contract, and client expectations, Assures MDRP consistency with contracted scope of work, and ICON SOPs and procedures.
• Reviews the electronic Case Report Form (eCRF), and CRF Completion Guidelines (CCG)
• Manages queries in cooperation with ICON MD, Sponsor, and other departments.
• Participate in or attend internal and client kick-off meetings, as needed.
• Reviews the protocol together with the ICON MD to determine which standard listings will be appropriate for medical review and decides whether any customized listings are needed per study specific requirements.
• Reviews and approves all test outputs of listings in collaboration with the MD and Biometrics teams.
• Plans and coordinates together with MD the medical review cycles and runs standard / customized listings as needed according to timeline.
• Ensures a structured medical query management.
• Raises and responds to medical queries following through until query resolution.
• Reviews and responds to medical queries to Quality Control (QC) findings, as needed.
• Supports business development activities by providing input into feasibility activities related to medical data review.
Qualifications:
• Degree in a Health Profession (E.g., Medical Doctor, Nurse, or Pharmacist)
• A minimum of 2 -3 years of relevant experience in clinical trial industry.
• Good understanding of the protocol and other relevant study documents.
• Exceptional written and verbal communication skills in English
• Demonstrated ability to organize and prioritize tasks efficiently to meet project goals.
• Solid knowledge of medical terminology and coding systems and confidence in your ability to review medical data
Benefits of Working in ICON
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON 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, 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.
Interested in the role, but unsure if you meet all 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.
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