Pharma-Consultant @ WIPRO , HEALTHCARE LIFESCIENCES SERVICES
Responsibilities:
Understanding of clinical documents (Safety , Submission and R& D related
documents) Set up, implement and maintain an eTMF (Trial Master File) in
accordance with the DIA reference model Oversight of compliance alongside
quality functions and data privacy requirements Ensure the completeness of the
Trial Master File (TMF) for assigned clinical studies Identification and
categorizing of clinical trial documents Quality checking of documents for
legibility, duplicity and completeness Identification of various properties and
features of clinical documents Provide support to Clinical Document QC
Specialist with regards to ICH/GCP documentationWorking Experience / Skill set
in: Clinical document management system Clinical research monitoring, pharmaceutical,
CRO or healthcare industry Knowledge of ICH GCP, 21 CFR part11 Working
knowledge of clinical essential documents, including trial master file Relevant
clinical research experience in industry or in clinical practice as a
trial/study coordinator
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