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.
Job Overview:
The Medical Data Reviewer (MDR), in close cooperation with the Medical Director (MD), sets up and coordinates the medical data review process, assists with medical data review and manages medical queries. The MDR role requires a close collaboration with various members of the Biometrics team, most frequently but not limited to the Data Coordinator & Lead Data Manager and Clinical Data Scientist. Specifically, the MDR reviews medical data for consistency and medical plausibility and ensures that the data is comprehensive from a medical point of view across different studies and projects.
Responsibilities:
The role:
• Prepares listings with medical data (vital signs, lab data, medical history, concomitant medication, etc.) for medical review for plausibility and consistency.
• Under close supervision, coordinates and drafts the Medical Data Review Plan (MDRP) according to PRA standards, contract and client expectations (AWARD report / Proposal). Assures MDRP consistency with other project plans i.e. Data Management Plan (DMP), Edit Check Plan, Data Transfer Plan (DTP)), contracted scope of work, and PRA SOPs and procedures
• Under close supervision, coordinates project-specific tasks such as review of the electronic Case Report Form (eCRF), and CRF Completion Guidelines (CCG).
• Manages queries and Data Clarification Forms (DCF) in cooperation with PRA MD, Sponsor and other departments.
• Participates in or attends internal and client Kick-Off meetings, as needed.
• Reviews the protocol together with the PRA MD to determine which Standard Objects 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 team.
• 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 Quality Control (QC) findings, as needed
• Supports business development activities by providing input into feasibility activities related to medical data review
Qualifications:
You will need:
• A Minimum of 2 years of experience of relevant clinical Trials industry experience
• Degree in Health (E.g., Nurse, Pharmacist)
• Basic knowledge of medical terminology and coding systems
• Advanced English for Reading, Writing and Speaking
• Excellent written and verbal communication
Advanced Office Pack
Experience working within a CRO / Pharma is highly preferred
Knowledge of ICH guidelines
Note: Hybrid Position: 2 days at home, 3 days at the office
Benefits of Working in ICON:
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.
At 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.
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, 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 through the form below.
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