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Job Summary

Senior Clinical Data Coordinator Job Description

We are seeking a highly organized and detail-oriented Senior Clinical Data Coordinator to join our team. The ideal candidate will have excellent communication skills, the ability to work effectively in a team environment, and strong organizational skills.

  • Document Management: Responsible for project-specific and departmental document tracking and control activities.
  • CRF Reviews: Reviews CRF (as per protocol) and project-specific documents to ensure accuracy and compliance.
  • Data Management: Initiates project-specific DMTMF (Data Management Trial Master File) and e-filing, reviewing it on an ongoing basis to maintain data integrity.
  • Document Preparation: Prepares project-specific documents, ensuring they meet the required standards and regulations.
  • Client Support: Handles requests/issues by the client and team, in coordination with the Project Manager.
  • Database Design: Coordinates with CDA in User Acceptance Testing (UAT), leading to robust database design.
  • Procedure Verification: Performs procedure verification as a part of database validation.
  • Data Clarification Forms: Creates, reviews, processes, and tracks Data Clarification Forms, updating clinical databases for ensuring data validity as per the protocol.
  • Data Listings: Conducts manual data listings as needed.
  • Training and Development: Assists in maintenance of the documents for Pre-production and Pre-lock audits and conducts project and process specific training for subordinates.
  • Back-up Support: Acts as a back-up for Data Manager.
  • SOP Compliance: Assists in preparation/review of departmental SOPs and conducts basic QC functions for departmental activities.
  • SOP Compliance: Ensures SOP compliance in project deliverables.
  • Compliance: Ensures compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies etc. for conducting delegated activities.

Responsibilities

Key Responsibilities:

The ideal candidate will be responsible for: