Lead Clinical Data Specialist

hace 4 días


Buenos Aires, Buenos Aires C.F., Argentina Indero A tiempo completo

At Indero, we are seeking a highly skilled Lead Clinical Data Specialist to join our team of experts in dermatology and rheumatology. As a key member of our Biostatistical study teams, you will be responsible for leading the development, maintenance, and validation of clinical trial data.

Key Responsibilities:
  • Develop and maintain annotated Case Report Forms (aCRFs) according to protocol, eCRF, and Innovaderm and/or Sponsor's standards and interpretation of CDISC SDTM Implementation Guideline (IG) and Controlled Terminology (CT).
  • Create specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets (or derived datasets, as applicable), Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to, Data Monitoring Committee (DMC) data review meetings, Interim Analyses (IAs), and Clinical Study Reports (CSR).
  • Review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and various Data Management (DM) documents (e.g., electronic Case Report Forms [eCRFs], edit checks, etc.).

You will work collaboratively within Biostatistical study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Innovaderm standard operating procedures (SOPs) and processes.


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