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Senior Clinical Data Programmer

2+ years
Not Disclosed
10 Dec. 18, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Senior Clinical Data Programmer
Location: India

Job Description:

We are looking for a Senior Clinical Data Programmer to join our Data Management department at Novotech. The primary responsibility of this role is to handle programming activities on clinical trial projects and ensure compliance with Good Clinical Data Management Practices (GCDMP).

Minimum Qualifications & Experience:

  • Education: Graduate in information science or a life science-related field, or similar.
  • Experience: At least two years in a similar role in a CRO or pharmaceutical company.
  • Technical Skills: Preferably with hands-on experience with Custom Functions/C# and Veeva EDC.

Responsibilities:

  • Design and implement clinical databases for clinical trial projects.
  • Program data review listings and data reconciliation.
  • Ensure compliance with SOPs and ICH-GCP quality standards.
  • Responsible for the design, programming, testing, and maintenance of clinical trial databases across various clinical trial applications.
  • Perform external data loads (labs, ECGs, etc.) and act as liaison with vendors to establish data transfer specifications.
  • Develop, validate, and maintain clinical trials built in various EDC applications.
  • Annotate CRFs according to CDISC guidelines or sponsor-specific metadata for case report tabulation (CRT) data sets.

Why Novotech?

Novotech is committed to providing an inclusive work environment that values diversity. We offer flexible working options, paid parental leave, wellness programs, and ongoing development opportunities. As a Circle Back Initiative Employer, we guarantee to respond to all applicants. We encourage applications from individuals passionate about clinical research and biotech, including LGBTIQ+ individuals, those with disabilities, and caregivers.

About Us:

Novotech is a leading Asia-Pacific biotech CRO, with offices in 11 countries and partnerships with key medical institutions. We offer services across all clinical trial phases and therapeutic areas, including feasibility assessments, data management, statistical analysis, medical monitoring, and regulatory submissions. With ISO 27001 certification and a focus on the highest IT security and quality standards, Novotech is dedicated to providing innovative solutions for clinical trials globally.