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Senior Clinical Data Specialist

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Job Overview:

We are seeking a skilled Clinical Data Coordinator to join our team.

  • Key Responsibilities:
  • Project-specific and departmental document tracking and control activities
  • CRF (as per protocol) and project-specific documents reviews
  • Initiating project-specific DMTMF (Data Management Trial Master File) and e-filing with ongoing review
  • Preparing project-specific documents
  • Handling client and team requests/issues in coordination with the PM
  • Leading User Acceptance Testing (UAT) with CDA for robust database design
  • Procedure verification as part of database validation
  • Creating, reviewing, processing and tracking of Data Clarification Forms and updating clinical databases
  • Manual data listings as needed
  • Maintenance of Pre-production and Pre-lock audits documents
  • Conducting project and process specific training for subordinates
  • Acting as a back-up for Data Manager
  • Assistance in preparation and review of departmental SOPs
  • Basic QC functions for departmental activities
  • Ensuring SOP compliance in project deliverables
  • Compliance to applicable rules, regulations, guidelines and policies for conducting delegated activities

Requirements:

A suitable candidate will possess excellent organizational skills, attention to detail, and strong communication abilities. Proficiency in data management software and systems is required.

Benefits:

This role offers a competitive salary package, comprehensive benefits, and opportunities for career growth and development.

What We Offer:

A dynamic work environment, collaborative team culture, and a range of employee benefits and perks.