Safety Data Coordinator

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.

The Safety Data Coordinator performs medical coding tasks commensurate with medical coding conventions and processes for multiple studies in different therapeutic areas.  The Senior Medical Coder is a subject matter expert in the area of Medical coding and industry standard coding dictionaries (MedDRA and WHODrug Dictionaries).

• Analyze and evaluate clinical data terminology (medical history verbatim, adverse experiences and/or concomitant medications) for coding purposes.
• Recognize and initiate resolution of data inconsistencies with subsequent follow-up until satisfactory resolution.
• Ensure medical accuracy, consistency and integrity of the dictionary system by concise coding by thorough term/drug research and definition.
• Create/maintain ad-hoc computer procedures utilized in generating subset dictionary listings for sponsor review and approval.
• Demonstrate initiative and ability to work under pressure to organize work requests and set priorities as defined by sponsor driven project milestone deadlines.
• Write coding SOPs and study specific guidelines.
• Maintain Clinical Data Management SOPs.
• Clinical Data Management contact for coding related questions and/or query resolutions.
• Sponsor contact for study related questions and/or query resolutions.
• Interact with various Data Management and other functional area colleagues, including, but not limited to: Biostatistics and Programming, Clinical, Project Management, Safety, site personnel, etc.
• Provide assistance, mentoring, and/or training to Clinical Data Management staff such as Clinical Data Coordinators and/or Data Entry staff, as necessary.
• Proactively makes recommendations regarding new tools and methods
• Possesses expert knowledge of coding applications, databases, processes and tools and serves as a coding liaison for cross functional groups such as Global Patient Safety and Medical Directors.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results
• Proactively makes recommendations regarding the development of coding conventions and procedures related to Medical Coding.

Education and Work Experience:

• At least a Bachelors of Nursing or Science, Bachelors of the Arts OR at least 5 years Clinical experience, either in-house or in the field
• Minimum 3-4 years experience in Data Management
• Knowledge, Skills, and Abilities:
• Knowledge of ICH and GCP guidelines
• Knowledge of medical terminology with emphasis on anatomy and physiology
• Demonstrate knowledge of the Clinical Trial Process
• Demonstrate knowledge of the Data Management Process
• Knowledge of Drug Development Process
• Ability to think critically and use good problem solving skills
• Attention to detail
• Strong organizational and time management skills
• Excellent verbal and written communications skills
• Knowledge of the MedDRA and WhoDrug classification dictionaries
• Knowledge of ClinTrial, SQL, MS Word, Excel, PowerPoint
  
  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.