Job Description
Job Title: Sr. Medical Coding Specialist
Location: REMOTE
Duration: 12 Months
Core Essential Skill Sets candidates must have:
1. 5 years of medical coding in a pharmaceutical or clinical research setting. [Note: this is not a medical billing/diagnostic coding position using ICD-10, CPT, etc.]
2. RN with Bachelor degree
3. Recent experience with both MedDRA and WHODrug coding, including ATC coding based on indication and route
4. Experience with Medidata Rave Coder and Veeva Vault Coder required. Ability to code using these tools with MedDRA and WHODrug required (will consider candidate with experience only with Rave Coder).
5. MedDRA, WHODRUG, MSSO MedDRA Browser, WHODrug Browser or equivalent.
Job Description
Ensures all coding is complete and without discrepancies prior to database clean/lock and documentation is stored in relevant folders. Assists in maintenance activities for coding databases,
including version upgrades, enhancement of coding algorithm and synonym tables.
Follows Client Safety, Health, and Environmental policies and procedures.
Conducts other projects and tasks as assigned.
Reports To: Director, Medical Coding
Education and Knowledge Requirements:
Sr. Medical Coding Specialist - Project Consultant must have 5 or more years of medical coding experience in a pharmaceutical or clinical research setting.
[Note: this is not a medical billing/diagnostic coding position using ICD-10, CPT, etc.]
RN with Bachelor degree or higher is preferred. PharmD also considered.
Candidates with lesser education may qualify if experience and demonstrated skills are commensurate.
Candidates must have recent experience with both MedDRA and WHODrug coding, including ATC coding based on indication and route.
Experience with various coding systems used in a pharmaceutical or clinical research setting.
Experience with Medidata Rave Coder and Veeva Vault Coder required.
Ability to code using these tools with MedDRA and WHODrug required (will consider candidate with experience only with Rave Coder).
Experience with all of the following coding dictionaries and browsers: MedDRA, WHODRUG, MSSO, MedDRA Browser, WHO Drug Browser or equivalent.
Experience in directly overseeing service providers is desired.
Excellent oral and written communication skills, interpersonal skills and leadership qualities.
Proven success working in a virtual, global, and multi-cultural environment.
Ability to multitask, prioritize and work effectively under pressure.
Ability to interact effectively and diplomatically with multifunctional areas and as a department/study team member.
Good Information Technologies orientation.
Proficiency using Microsoft Office products, including but not limited to Excel, Word, PowerPoint; Experience using MS365, One Drive, Teams is desired.
Professional accuracy, integrity, dedication, and motivation.
Critical thinking/problem solving skills.
Understanding of FDA and international regulations and GCP
Primary purpose and function of this position:
Responsible for delivering accurate and consistent medical coding for all assigned company protocols within established timelines and in compliance with processes, guidelines, and conventions.
The Sr. Medical Coding Specialist - Project Consultant will serve as a coding lead for assigned clinical studies, ensure creation of Medical Coding Plan (MCP) at study start-up, and will provide Quality Control (QC) review of coding provided by outsourced service providers.
Additionally, the Medical Coding Specialist - Project Consultant will assist management with improving and maintaining the coding database infrastructure, processes and may mentor/train other medical coding staff.
Major duties and responsibilities:
Oversees all coding activities performed by service providers for assigned studies.
Performs in-house coding for assigned studies.
Ensures accurate coding of medical terminology using MedDRA and WHODrug or other company coding tools in accordance with company coding conventions, process, SOPs, and regulatory requirements.
Leads medical coding startup activities which include creation of the Medical Coding Plan and may involve consulting with the Clinical Study Physician (CSP) or their designee.
Serves as coding lead for active clinical trial(s) and/or therapeutic group of studies for assigned trials.
Attends study team meetings with active interaction with stakeholders across functional areas to ensure coded data is captured appropriately, approved, and delivered within established timelines.
Performs QC of coding outsourced to service providers. Identifies and provides requests for data clarification for data that cannot be coded and coding change requests, if necessary. Performs QC of internally coded studies as needed.
Develops positive partnerships with CROs and ensures a high standard of deliverables are maintained.
Provides feedback/guidance to service providers, CSP, and Data Management to assist in the resolution of coding issues.
Coordinates reviews by the CSP during the study and facilitate the generation of queries for questions raised after medical review.
Provides coding/dictionary information as requested to the CSP to facilitate coding review and medical monitoring
Discusses final coding with the CSP and facilitates the coding approval process to ensure coding is approved prior to interim and final database clean/lock activities.
Job Tags
Permanent employment, Interim role, Remote job,