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Clinical Coding Specialist

2.00 to 6.00 Years   Hyderabad   09 May, 2021
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

Job Title: Clinical Coding SpecialistJob Location: Anywhere in India ( Full time home based)Job Overview:Perform medical coding of free texts collected in the course of a clinical trial or from other sources, taking into account appropriate coding guidelines.Job Duties and Responsibilities:The specific job duties of a Clinical Coding Specialist may include but are not limited to:

  • Assign codes to unambiguous reported terms according to agreed coding guidelines for a given project
  • Identify the need for further clarification of ambiguous reported terms and create appropriate queries
  • Communicate issues that require sponsor decision, including proposal for a solution
  • Ensure consistent code assignment within a project by reviewing coding and re-assignment of terms, if necessary
  • Provide independent review of data coded by third parties, if needed.
  • Provide support to other departments concerning dictionary use and code assignment
  • Development of project-specific coding guidelines and coding review processes in cooperation with the sponsor and the Lead Clinical Data Manager
  • Provide input to protocol writing, database setup and CRF design process with respect to coding
  • Supports and tracks budget adherence in cooperation with Finance to ensure the assigned deliverables are meeting targeted margins and utilization
  • Continuous improvement of departmental processes and procedures to ensure DM is consistently maximizing efficiencies, leveraging technology and incorporating innovation to optimize delivery
  • Maintains working knowledge of regulatory requirements/guidance as well as industry leading best practices to ensure Clinipace DM procedures are in line with industry expectations
  • Assist in training new staff
  • Other duties as assigned
Supervisory Responsibilities: NoneJob Requirements:
  • Education
    • Qualified medical documentalist or LPN, RN degree (preferably with experience as study nurse) or qualification on same level within a medical or scientific field
  • Experience
    • Minimum of 2 years professional experience in the pharmaceutical industry or at a CRO
    • Clinical Research industry experience in Data Management or Clinical Coding considered.
  • Skills/Competencies
    • Knowledge of at least one standard coding dictionary (e.g. MedDRA, WHODrug, ATC)
    • Proficiency in medical terminology as well as body systems/anatomy, physiology, and concepts of disease
    • Comprehensive knowledge of GCP/ICH guidelines
    • Able to exercise judgment within defined procedures and practices and to determine appropriate action independently
    • Good overview of all systems linked to the coding process, and understanding of their interactions and dependencies
    • Good understanding of Clinical Data Management process
    • Good working knowledge of clinical database systems
    • Good level of English (verbal and written)
    • Strong problem-solving abilities (technical, interpersonal, and decision making)
  • Capabilities
    • Strong computer skills, including Microsoft Office
#LI-XX1 V2The company will not accept unsolicited resumes from third party vendors.,

Keyskills :
problem solvingcrf designcomputer skillsclinical datadata managementpharmaceutical industrymedical codingmedical terminologyprotocol writingclinical data managementstatements of work sow

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