Veeva CTMS/ eTMF Technical Expert with Clinical Operations Management

8 - 13 years

10 - 20 Lacs

Posted:None| Platform: Naukri logo

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Work Mode

Hybrid

Job Type

Full Time

Job Description

Hands-on Technical SME for Clinical Operations

  • Area of expertise: Clinical early phase systems and associated study supported tools
  • Knowledge with study set up, participant enrollment, randomization, investigational product dispensing, trial supply inventory management and participant visit tracking.
  • Hand on experience with Evident IQ Marvin, Planisware, Almac IRT, SOCAR eSOCDAT, Clinical ink eLAS.
  • Experience with Veeva Clinical CTMS, eTMF, and CDMS systems.
  • Knowledge of SQL, database management, and data analysis.
  • Familiarity with clinical data standards (e.g., CDISC, SDTM).
  • Experience with cloud-based solutions and SaaS platforms.
  • Understanding of GxP, 21 CFR Part 11, and other regulatory requirements.
  • Statistical analysis tools SAS server, PC SAS, R studio, Qlik, CDISC tools Pinnacle 21, RYZE experience is a plus.
  • Functional knowledge of clinical trials and correlation with clinical systems is added advantage.

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