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Technical Data Manager Ii – India

3+ 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

Technical Data Manager II – India

Excelya | Full-time | Permanent Contract | India

Excelya, a leading Contract Research Organization (CRO) in Europe, is seeking a Technical Data Manager II to oversee technical aspects of Clinical Data Management (CDM). This role requires expertise in EDC database design, data validation, and compliance with ICH-GCP, EU, and FDA guidelines.

Key Responsibilities

Technical Data Management

  • CRF (Case Report Form) design and screen development in the EDC database.
  • Write and implement Data Validation Plans (DVPs), including edit check programming.
  • Maintain global libraries in the EDC system to ensure consistency across studies.
  • Write listing specifications for data validation and study monitoring.
  • Work closely with the Lead Data Manager to ensure efficient execution of study protocols.

Regulatory Compliance & Documentation

  • Adhere strictly to Excelya and client SOPs, international guidelines, and local regulations.
  • Archive study documentation as per regulatory and organizational standards.

Administrative & Other Responsibilities

  • Complete Excelya administrative tasks (e.g., timesheets, CV updates, training).
  • Support additional tasks assigned by supervisors as needed.

Minimum Requirements

  • Bachelor’s degree in a scientific discipline (preferred).
  • 3+ years of experience as a Technical Data Manager or equivalent.
  • Strong knowledge of ICH-GCP, EU/FDA guidelines, and CDM best practices.
  • Experience with clinical trial databases, data flow, and eCRF 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).
  • Willingness to travel up to 25% as needed.

📍 Location: India