Shire Veteran Jobs

clinical safety coder iii.

• north chicago , illinois (remote)

• posted 10 days ago

job details

summary

• $37 - $54.41 per hour

• contract

• bachelor degree

• category life, physical, and social science occupations

• reference47985

job details

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!

location: North Chicago, Illinois

job type: Contract

salary: $37.00 - 54.41 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

• Effectively performs coding & related functions for assigned studies. Prepare and manage coding assignments for new studies and collaborate with clinical team representatives on approach to coding strategy for assigned products and oversight of assigned studies including sign off of document as it impacts medical coding review, product approval, analysis of coded data for safety review and signal detection and patient safety.

• Identifies when terms or drug names are inadequate, ambiguous or unclear for coding purposes and direct query generation in such aspects. Also, identify and resolve coding discrepancies; and review coding listings for accuracy and consistency.

• Participate in identification of clinical trial prohibited meds, exclusionary medical history and appropriately issue escalation.

• Participate in the development of coding conventions, Standard Operating Procedures and Work Practices as a member of coding team.

• Keep abreast of coding guidelines internally and externally. Provide consultation to safety reviewers, study physicians, and clinical team members regarding study specific coding questions. Does not initiate strategic decisions, but is responsible for supporting the department, division and company's strategic direction.

• Provide Coding training/overview to Clinical team members, Clinical Research Organizations, Investigators and investigator sites as needed, in support of clinical trials.

• Impacts medical coding quality and consistency and resultant ability to complete analysis of coded data for safety review, signal detections, issue identification, pro duct approval and patient safety.

qualifications:

• Bachelor's degree with related health science background required (e.g. Nursing, Pharmacy). A relevant coding experience with a minim um of 2-4 year drug safety/ pharmacy experience or 2-4 years clinical and 2-4 years drug Pharmacy experience preferred but not required.

• Must have a strong understanding and utilization of medical terminology. Experience in coding medical data (adverse events and concomitant medications) and understanding of the clinical coding process is preferred. Working knowledge of MedDRA, and WHO¬DD is strongly preferred.

• Working knowledge of Clinical trial data systems and/or EDC coding tools is a plus.

• Must be detail¬ oriented with the ability to identify discrepancies in clinical data and to handle multiple projects and priorities

• Demonstrates effective interpersonal and communication skills. Ability to accurately retrieve data for safety or other analysis.

• Ability to contribute to the definition and timely achievement of area projects and goals and serve as a representative for Coding on cross functional projects.

• Problem solving skills should involve identification of problems and proper escalation to Coding management.

• Follow global coding conventions and guidelines and identify medical coding needs and requirements.

• Must have absolute resolution of medical coding data completeness regarding all aspects of safety management utilizing basic knowledge of regulatory guidance's/ practices.

• Must be able to work independently as well as in a team environment and effectively collaborate with stakeholders for effective outcomes.

Requirements:

• MedDRA Coding

• WHODD Coding

• ATC Coding

• Recent use of TMS Platform

• Medidata Experience preferred (not required)

• Familiarity of MedDRA Browser and UMC Insight Tool

• Work Hours: 8:00am to 5:00pm Central Standard Time (occasional flexibility can be discussed with prior approval)

• Flexible to work overtime if needed

skills: EDC (Electronic Data Capture), MedDRA

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

Applications accepted on ongoing basis until filled.