Wipro Infotech looking for Pharma Consultant

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Wipro Infotech is the leading strategic IT partner for companies across India and Middle East - offering integrated IT solutions. We plan, deploy, sustain and maintain your IT lifecycle through our total outsourcing, consulting services, business solutions and professional services. Wipro Infotech helps you drive momentum in your organisation - no matter what domain you are in.

Post : LS - Pharma-Consultant

Job Description:   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 documentation  

Working 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

Additional Information
Qualification : M.Pharm
Experience : 10 yrs
Location : Kolkata
Industry Type : Pharma
End Date : 10th December, 2019

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