Ensures accurate and consistent coding of medical data, including but not limited to, adverse event verbatim descriptions and medication data received from global clinical trials across all clinical areas including identification of prohibited medications and exclusionary medical history. Participates in Centralized Clinical Coding Group (CCCG) process improvement initiatives and serves as a subject matter expert and primary coding resource for assigned compounds and studies.
Primary coding resource for assigned products and studies. Accurately codes assigned data fields including, but not limit ed to, adverse events using MedDRA and concomitant medications using WHO Drug in accordance with company coding conventions and ATC.
location: Telecommute
job type: Contract
salary: $40.00 - 47.83 per hour
work hours: 8 to 4
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:
Required:
- Bachelor's Degree: Health Science (Nursing, Pharmacy)
- Strong Medical Terminology Understanding
- Detail-Oriented (Clinical Data Discrepancies)
- Data Retrieval (Safety Analysis)
- Global Coding Conventions/Guidelines
- MedDRA Coding
- WHODD Coding
- ATC Coding
- Recent TMS Platform Use
- MedDRA Browser/UMC Insight Tool Familiarity
- 8:00 AM - 5:00 PM CST Availability with Overtime Flexibility
- Coding Experience (Adverse Events/Medications)
- Medidata Experience
- 2-4 Years Drug Safety/Pharmacy or Clinical/Pharmacy Experience
- Project/Goal Contribution
- Problem Solving/Escalation
- Independent/Team Work & Collaboration
- Regulatory Guidance Knowledge
skills: MS-WORD, MS-EXCEL, MS-Powerpoint, GCP (Good Clinical Practice), Drug Safety, 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).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
