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AI Summary
The role involves coding medical terminology according to GCP and SOPs while ensuring accuracy and quality of deliverables. Additionally, the specialist provides guidance, training, and mentoring to the CDM project team.
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Senior Coding Specialist I – Make an Impact at the Forefront of InnovationWe have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Senior Coding Specialist I, you will code medical terminology in accordance with Good Clinical Practices (GCP), Standard Operating Procedures (SOPs)/Working Practice Documents (WPDs), and Data Validation Manuals (DVMs).
What You’ll Do:
• Codes medical terminology and reviews coding listings in accordance with the Coding Plan in the DVM. Identifies data issues and works with PPD team and study sites to resolve. Ensures coding accuracy according to departmental operating procedures. Ensures all coding aspects are conducted accurately, and all coding deliverables are completed to quality expectations, within budget and on time.
• Assists in providing general and project specific coding training to all CDM staff performing coding activities.
• Provides support, guidance and direction on all coding aspects to the CDM project team.
• Produces project-specific status reports for supervisor and for clients on a regular basis.
• Acts as a mentor providing ongoing advice and guidance to the Coding Specialists
Education and Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
• Applies knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations
• Excellent understanding of clinical/medical terminology
• Strong attention to detail and skill with numbers
• Ability to use interactive computer programs
• Good written and verbal communication skills
• Good organizational skills
• Good analytical/problem-solving skills
• Ability to work productively with minimal supervision
• Ability to maintain a high degree of confidentiality with medical records and client's proprietary data
• Ability to attain, maintain and apply a working knowledge of GCPs and applicable SOPs
• Strong customer focus and excellent interpersonal skills.
• Proven flexibility and adaptability
• Ability to work in a team environment and independently as needed
• Demonstrated good judgment in making decisions
• Ability to set and meet timelines or be able to negotiate schedule changes in response to project demands
Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.
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