Coding Specialist

Malvern, PA

Posted: 09/19/2019 Job Number: JN -092019-11122
Senior Coding Specialist

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Title: Senior Coding Specialist
  • Location: Malvern, PA
  • Industry: Pharmaceutical
  • Hours: Monday-Friday; 8:00 am-5:00 pm
  • Salary: $40.00-$45.00/hr.
  • Employment Type: 6-month contract with possibility to go perm
Environment: This client is a worldwide leading generic pharmaceutical company and one of the top 15 companies in the industry. With over 45,000 employees in 60 countries worldwide, they are proud to say that our employees are the reason for our success . They believe in empowering employees, presenting them with new challenges and letting them grow and develop professionally. Isn t this the type of company you want to work for?


Position Summary: 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 Senior Coding Specialist 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 Senior Coding Specialist will assist management with improving and maintaining the coding database infrastructure, processes and may mentor/train other medical coding staff.

Responsibilities:
  • Oversees all coding activities performed by service providers for assigned studies. Performs in-house coding as needed.
  • 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 proactive 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.
    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.
  • 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 Safety, Health, and Environmental policies and procedures.
  • Conducts other projects and tasks as assigned.
Requirements:
  • Senior Coding Specialist must have 5 or more years of medical coding experience in a pharmaceutical or clinical research setting. (3 or more years for Coding Specialist).
  • RN with bachelor s degree or higher is preferred.
  • Experience with various coding systems used in a pharmaceutical or clinical research setting.
  • Experience with Medidata Coder a plus
  • Experience with all of the following coding dictionaries and browsers: MedDRA, WHODRUG,
  • MSSO MedDRA Browser, WHODrug Browser or equivalent.
  • Candidates must have recent experience with both MedDRA and WHODrug coding, including ATC coding.
  • Experience using SQL statements and TOAD software for searching and reviewing data a plus.
  • Experience in directly managing/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.
  • Good Information Technologies orientation.
  • Professional accuracy, integrity, dedication and motivation.
  • Critical thinking, influence and problem-solving skills.
  • Understanding of FDA and international regulations and GCP.
EOE/ADA
Search words: clinical coding, pharmaceutical coding, medical coding plan, Medidata Coder, MedDRA, WHODrug, SQL statements, TOAD software

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