Instagram
youtube
Facebook

Edc Programmer

5-8 years
Not Disclosed
10 Feb. 6, 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

EDC Programmer Role – TCS, Mumbai

📍 Locations: Mumbai, Pune, Bangalore, Indore, Ahmedabad
📅 Experience: 5 - 8 years
📅 Apply By: 02-Apr-2025

Job Description:

Tata Consultancy Services (TCS) is hiring for an EDC Programmer role!

Key Responsibilities:

  • Interpret clinical study protocols to incorporate data points into specifications.
  • Ensure transparency with study teams regarding timelines and potential delays in eCRF development.
  • Collaborate with Data Managers and actively participate in study discussions.
  • Lead and conduct eCRF Design Meetings, documenting key decisions and issues in Project Binder.
  • Develop eCRF screens as per specifications using Veeva Studio.
  • Configure SDV/SDR, Safety, and Coding within the Veeva CDMS tool.
  • Review edit check specifications for clarity and alignment with eCRF design.
  • Program study-specific checks, protocol deviation checks, and email checks following Veeva best practices.
  • Validate and perform developer-level testing to ensure accuracy and compliance.
  • Provide UAT details to the Validation Team and Study Data Manager.
  • Facilitate the Go Live process, ensuring training details are communicated to the Study Data Lead (SDL).
  • Review and promote study documents such as SDS, Annotated eCRF, TandE, Blank eCRF in the eTMF system.
  • Confirm all required documents are properly stored in eTMF and Project Binder within Veeva.

Desired Candidate Profile:

Educational Qualifications:

  • Bachelor’s Degree: Pharmacy (B.Pharm), Science (B.Sc)
  • Master’s Degree: Pharmacy (M.Pharm), Science (M.Sc)

📌 Job Function: Business Process Services
📌 Role: Executive
📌 Required Skills: Veeva Vault