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Senior Clinical Data Manager (Sr. Cdm) – India

5+ 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

Senior Clinical Data Manager (Sr. CDM) – India (Full-Time, Permanent)

Excelya | Full-Time | Permanent | Bangalore, India

Excelya, a leading independent CRO in Europe, is seeking a Senior Clinical Data Manager (Sr. CDM) based in Bangalore, India. This role offers an opportunity to work on high-quality data management tasks for clinical studies while ensuring compliance with regulatory standards and Client SOPs.

Key Responsibilities

  • Adhere to Excelya & Client SOPs to ensure compliance with ICH-GCP, FDA, and EU regulations.
  • Perform data cleaning, discrepancy management, and reconciliation activities for assigned studies.
  • Work closely with the Lead Data Manager to support clinical data operations.
  • Generate study metrics and status reports across multiple studies.
  • Participate in EDC database build, testing, and go-live processes.
  • Oversee junior staff and provide mentorship.
  • Act as a Lead Data Manager for simpler studies.
  • Ensure proper archiving of study documentation.
  • Complete administrative tasks, including timesheets, CV updates, and training records.

Required Skills & Qualifications

  • Bachelor’s degree in a Scientific discipline (preferred).
  • 5+ years of experience in Clinical Data Management.
  • Strong understanding of ICH-GCP, CDM best practices, and regulatory guidelines.
  • Experience with clinical trial databases, data review, and eCRF design.
  • Understanding of clinical trial lifecycle (start-up, maintenance, closeout).
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint, MS Project, etc.).
  • Excellent verbal and written communication skills in English and the local language.
  • High level of professionalism, ethics, and compliance.

This role provides an opportunity to lead data management activities while contributing to Excelya’s mission of advancing clinical research in Europe and beyond.