Parexel Hiring Clinical Data Coder I
About Company:
Parexel, a leading global clinical research organization, is seeking a Clinical Data Coder I to join our team in Bengaluru. With 2 to 4 years of experience, you will play a crucial role in clinical data coding, ensuring compliance with corporate quality standards and international regulatory requirements.
Position: Clinical Data Coder I
Organization: Parexel
Qualification: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Experience: 2 to 4 Years
Salary: ₹5 – 9.5 Lacs Per Year
Location: Bengaluru
Responsibilities:
Clinical Coding:
- Perform clinical coding using dictionaries (LLT, Drug Name).
- Identify ambiguous verbatim and issue queries.
- Provide regular status updates to supervisors.
- Act as backup coder.
- Provide inputs for process improvement.
- Report issues with coding and EDC system synchronization.
Coding Set Up, Reports, and Documentation:
- Assist in coding tool setup.
- Author/review Coding Documents.
- Assist in User Acceptance Testing.
- Participate in technical peer reviews and QC activities.
- Ensure documents are placed in eTMF systems.
- Generate Unique Terms Report (UTR).
Dictionary Management and Database Lock:
- Report discrepancies with clinical dictionaries.
- Address issues with DBL process and documentation.
Project Management & Compliance:
- Meet timelines for assigned studies.
- Address coding-related issues proactively.
- Comply with SOPs, manuals, trainings, and best practices.
- Ensure regulatory compliance (e.g., ICH-GCP).
Skills:
- Team collaboration and knowledge sharing.
- Attention to detail and commitment to First Time Quality.
- Good interpersonal, verbal, and written communication skills.
- Analytical and problem-solving skills.
- Fluency in English.
Knowledge and Experience:
- Strong knowledge of medical terminology and coding dictionaries (e.g., MedDRA, WHODrug).
- Knowledge of Clinical Trial/Data Management Systems (e.g., InForm, Rave, Veeva, DataLabs), and Microsoft Office.
- Understanding of Data Management processes and data flows.
- Experience in clinical coding.
- Understanding of regulatory requirements (e.g., ICH-GCP).
- Basic knowledge of QC and Setup, Conduct, and Close-Out of Coding Systems and Tools.