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Clinical Data Manager I (Cdmi) – India

1+ years
Not Disclosed
10 Feb. 10, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Clinical Data Manager I (CDMI) – India

Excelya | Full-time | Permanent Contract | Bangalore, India

Excelya, a leading independent Contract Research Organization (CRO) in Europe, is seeking a Clinical Data Manager I (CDMI) to support data management activities for clinical trials. The CDMI will work under the supervision of senior staff to ensure data integrity, compliance with ICH-GCP, and regulatory standards.

Key Responsibilities

Clinical Data Management

  • Perform data cleaning, data review, discrepancy management, and data reconciliation.
  • Work closely with the Lead Data Manager to ensure study data quality.
  • Generate study metrics and status reports across multiple studies.
  • Participate in EDC (Electronic Data Capture) database build and testing before go-live.
  • Archive study documentation as per regulatory and organizational standards.

Compliance & Best Practices

  • Adhere to Excelya and Client SOPs, ensuring regulatory compliance with ICH-GCP, EU, and FDA guidelines.
  • Ensure compliance with clinical trial databases and data management best practices.

Administrative & Additional Tasks

  • Complete administrative tasks like timesheets, CV updates, and training requirements.
  • Undertake additional tasks assigned by the supervisor.

Minimum Requirements

  • Bachelor’s degree (Scientific discipline preferred).
  • 1+ years of experience as a Clinical Data Manager or equivalent.
  • Strong knowledge of ICH-GCP, EU/FDA guidelines, and clinical data management best practices.
  • Experience with clinical trial databases, data review, and eCase Report Form design.
  • Understanding of the clinical trial lifecycle (start-up, maintenance, closeout).
  • Proficiency in MS Office (Word, Excel, PowerPoint, MS Project, etc.).
  • Fluent in English & local language (written and spoken).

📍 Location: Bangalore, India