Company: Thermo Fisher Scientific
PPD
Thermo Fisher Scientific Careers
Work Schedule: Standard (Mon–Fri)
Work Environment: Office
Employment Type: Full-time
1. Role Overview
The Senior Coding Specialist I is responsible for medical coding activities within Clinical Data Management (CDM), ensuring clinical trial data is accurately coded using standardized medical terminology dictionaries and in compliance with GCP, SOPs, and coding plans.
The role combines:
Clinical terminology expertise
Data review and reconciliation
Quality control
Cross-functional support within clinical trials
This is a specialized data-focused clinical operations role.
2. Core Responsibilities
A. Medical Coding & Data Review
Code medical terminology according to:
Coding Plan
Data Validation Manual (DVM)
GCP/SOP standards
Review coding listings for:
Accuracy
Consistency
Completeness
Identify data discrepancies and support resolution with study teams and sites
B. Clinical Data Quality Management
Ensure coding deliverables meet:
Quality standards
Timelines
Budget expectations
Maintain coding accuracy throughout study lifecycle
Support clinical data consistency and integrity
C. Training & Mentorship
Assist in training CDM staff on coding procedures
Provide project-specific coding guidance
Mentor Coding Specialists and junior team members
D. Cross-Functional Support
Support Clinical Data Management (CDM) project teams
Provide coding-related consultation and issue resolution
Communicate coding status and challenges to stakeholders
E. Reporting & Documentation
Produce project-specific coding status reports
Maintain documentation according to SOPs and regulatory standards
Ensure confidentiality of medical and sponsor data
3. Required Qualifications
Education
Bachelor’s degree or equivalent qualification
Experience
Minimum 3 years of relevant experience in:
Medical coding
Clinical data management
Clinical trial operations support
4. Core Skills
Clinical & Coding Skills
Medical terminology expertise
Clinical coding workflows
Understanding of:
Clinical trial processes
GCP guidelines
SOP compliance
Data discrepancy identification and reconciliation
Technical Skills
Interactive coding/data systems
Clinical databases and coding tools
Report generation and tracking
Clinical data review systems
Analytical Skills
Strong numerical and analytical ability
Problem-solving capability
Attention to detail and accuracy
Behavioral Skills
Ability to work independently
Team collaboration and mentoring
Adaptability and flexibility
Strong organizational skills
Confidential handling of sensitive medical data
5. Key Skill Areas
Medical Coding
Clinical Data Management (CDM)
Clinical Terminology
GCP & SOP Compliance
Data Quality Review
Clinical Trial Data Operations
6. Typical Coding Dictionaries & Systems (Industry Context)
Although not explicitly listed in the JD, this role commonly works with:
MedDRA
WHO Drug Dictionary
Clinical coding and EDC platforms
7. Organizational Context
This role belongs to Clinical Data Management (CDM) operations within clinical research services.
The position supports:
Clinical trial data standardization
Regulatory-ready datasets
Accurate adverse event and medication coding
It is an important backend operational role in clinical trials.
8. Relative Career Positioning
Compared to the other roles you shared:
More Specialized In:
Medical coding
Clinical trial data standardization
Backend clinical data operations
Less Focused On:
Site monitoring
Medical writing
Regulatory strategy
Laboratory or manufacturing science
9. Career Progression Path
Typical progression:
Coding Specialist
→ Senior Coding Specialist
→ Lead Coding Specialist
→ Clinical Data Management Lead
→ Data Standards Manager
→ Clinical Data Operations Director
Uttar Pradesh :
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Hajipur | Patna |Kerala :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Frankfurt | Harveysburg |Germany :
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Gottingen | Hannover | Leipzig |Saxony Anhalt :
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Basel | Zurich |Serbia :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
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Wavre |Tipperary :
Ballydine |Cork :
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Swords |Republic of China :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Yavne | Tel Aviv | Kfar Saba | Netanya | Be'Er Sheva |Remote :
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