• Login / Signup
    • Instagram
    youtube
    Facebook

    Clinical Data Coder I

    Parexel
    2-4 years
    Not Disclosed
    Bangalore
    10 Aug. 22, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    About This Role: Clinical Data Coder I

    Position Overview:

    The Clinical Data Coder I (CDC I) is responsible for executing clinical data coding tasks with 2 to 4 years of relevant experience. This role involves coding clinical data, generating and integrating queries, and running reports under the supervision of senior coding staff or a line manager. All activities are performed in accordance with corporate quality standards, SOPs, ICH-GCP, and other international regulatory requirements.

    Key Responsibilities:

    1. Clinical Coding:

      • Perform clinical coding mapping using coding dictionaries, mapping to the nearest Low Level Term (LLT) or Drug Name as appropriate.
      • Identify ambiguous verbatim terms and issue queries according to applicable coding conventions.
      • Provide regular updates on work status to the direct supervisor or primary coder and sponsor.
      • Serve as a backup coder in the absence of the primary coder.
      • Contribute to process improvement initiatives.
      • Identify and report issues related to coding and EDC system synchronization.

    2. Coding Setup, Reports, and Documentation:

      • Assist in the setup of coding tools for assigned trials.
      • Author or review coding documents, including conventions, definitions, and configuration specifications.
      • Assist in executing User Acceptance Testing (UAT).
      • Support technical peer review and functional quality control (QC) activities of coding setups.
      • Ensure coding-related documents are appropriately stored in the eTMF systems.
      • Generate Unique Terms Report (UTR).

    3. Dictionary Management and Database Lock:

      • Report discrepancies observed with the clinical dictionary used.
      • Address issues related to the Database Lock (DBL) process and associated documentation.

    4. Project Management & Compliance:

      • Ensure all scheduled timelines are met for assigned studies.
      • Proactively report any coding issues to line managers, reviewers, and study teams.
      • Comply with applicable SOPs, manuals, training, and best practices.
      • Adhere to regulatory requirements (e.g., ICH-GCP).

    Skills:

    • Collaborative team player with the ability to work effectively in a team environment.
    • Quick learner with a knowledge-sharing approach; adept at understanding new technologies and processes.
    • Detail-oriented with a commitment to First Time Quality, including a methodical and accurate approach to work.
    • Strong interpersonal, verbal, and written communication skills.
    • Analytical and problem-solving abilities, including the capability to conduct root cause analyses.
    • Fluent in English, both written and oral.

    Knowledge and Experience:

    • In-depth knowledge of medical terminology and coding dictionaries (e.g., MedDRA & WHODrug).
    • Familiarity with Clinical Trial/Data Management Systems (e.g., InForm, Rave, Veeva, DataLabs) and Microsoft Office products.
    • Understanding of data management processes and data flows.
    • Demonstrated experience in clinical coding.
    • Knowledge of regulatory requirements (e.g., ICH-GCP).
    • Basic understanding of QC and the setup, conduct, and close-out of coding systems and tools.

    Education:

    • Bachelor’s degree or equivalent medical qualification or relevant experience in coding or data management.

    Latest Jobs

    Quality Specialist Ii - 100% Remote - Pharmacovigilance Compliance

    On-Board Companies
    Remote

    Medical Affairs Manager

    Us Tech Solutions
    Titusville

    Sr. Scientist - In Vivo Pharmacology (Inflammation Research)

    Amgen
    Remote, USA

    Associate Medical Safety Director

    Iqvia
    Belgrade

    Sponsor Dedicated Cra Ii

    Syneos Health
    Remote - Europe

    Cra Ii

    Syneos Health
    Remote, USA

    Clinical Research Scientist Ii

    Teva Pharmaceuticals
    Mumbai

    Sr. Pv Professional

    Teva Pharmaceuticals
    Bangalore

    Pv Professional

    Teva Pharmaceuticals
    Bangalore

    Scientist - Molecular Biology & Pharmacology

    Amgen
    San Francisco

    Pharma Jobs in India

    Andra Pradesh :

    Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji |

    Gujarat :

    Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |

    Haryana :

    Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Solan |

    Jharkhand :

    Ranchi |

    Karnataka :

    B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram |

    Madhya Pradesh :

    Dewas | Gwalior | Indore |

    Maharashtra :

    Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |

    PAN-India :

    Panjab :

    Punjab :

    Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |

    Rajasthan :

    Banasthali | Jaipur | Pilani | Udaipur |

    Tamil Nadu :

    Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |

    Uttar Pradesh :

    Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |

    Uttarakhand :

    Dehradun | Nainital | Rishikesh |

    West Bengal :

    Kolkata | Mukundapur |

    Pharma Jobs in United States

    Arizona :

    Chandler | Tempe | Tucson |

    California :

    Brisbane | Davis | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Mountain View | Nevada | Pasadena | Pleasanton | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | Santa Clara | Santa Monica | Simi Valley | Stanford | West Valley City |

    Colorado :

    Denver |

    Connecticut :

    Storrs |

    D.C :

    Washington |

    Florida :

    Coral Gables | Gainesville | Jacksonville | Orlando | Rueil-Malmaison | Tallahassee | West Palm Beach |

    Georgia :

    Atlanta |

    Hawaii :

    Honolulu |

    Illinois :

    Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Lawrence |

    Maryland :

    Baltimore | Rockville |

    Massachusetts :

    Boston | Cambridge | Medford and Somerville | Rockland |

    Minnesota :

    Minneapolis and St. Paul, Minnesota. |

    Missouri :

    Fulton | St. Louis |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |

    New York :

    Biddle | Buffalo | Ithaca | Morningside Heights | New York | Syracuse |

    North Caroline :

    Chapel Hills | Durham | Morrisville | Raleigh | Scottsdale |

    Ohio :

    Columbus, |

    Pennsylvania :

    Ambler | Philadelphia | Pittsburgh |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    Tennessee :

    Nashville |

    Texas :

    Austin | Dallas | Houston | Richardson |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Pullman | Seattle |

    WI :

    Madison | Wausau |

    Wisconsin :

    Pharma Jobs in Germany

    Baden-Wurttemberg :

    Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen |

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    Hesse :

    Marburg |

    Hessen :

    Frankfurt |

    Lower Saxony :

    Gottingen | Hannover | Leipzig |

    Mecklenburg Vorpommern :

    Rostock |

    Munich :

    Bavaria |

    North Rhine Westphalia :

    Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |

    Rhineland Palatinate :

    Mainz |

    Rotherbaum :

    Hamburg |

    Saarland :

    Saarbrucken |

    Saxony Anhalt :

    Halle |

    Schleswig Holstein :

    Kiel |

    Pharma Jobs in Europe

    Denmark :

    Copenhagen |

    Hungary :

    Budapest |

    Serbia :

    Belgrade |

    Switzerland :

    Basel |

    Pharma Jobs in Australia & China & Colombia & Croatia & Egypt & England & Ireland & Korea & Netherland & Remote & Saudi Arabia & Spain & Thailand

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Republic of China :

    Beijing |

    Tokiyo :

    Osaka | Tokyo |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    Salt Lake City | London |

    Republic of Ireland :

    Limerick | Dublin |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Remote :

    Remote, USA | Switzerland | Remote - Europe | Remote |

    Makkah :

    Najran | Khulais | Riyadh | Jeddah | Rabigh |

    Catalonia :

    Barcelona |

    Republic of Thailand :

    Bangkok |