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Clinical Data Leadership Role

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Senior Clinical Data Coordinator Job Description

We are seeking a highly skilled and experienced Senior Clinical Data Coordinator to join our team. The ideal candidate will have a strong background in data management, document control, training, quality control, and compliance.

Job Summary:

A Senior Clinical Data Coordinator is responsible for project-specific and departmental document tracking and control activities.

  • Reviews CRF (as per protocol) and project-specific documents to ensure accuracy and compliance.
  • Initiates project-specific DMTMF (Data Management Trial Master File) and e-filing, reviewing it on an ongoing basis.
  • Prepares project-specific documents, including data clarification forms and updates clinical databases for ensuring data validity as per the protocol.
  • Conducts manual data listings as needed and assists in maintenance of documents for Pre-production and Pre-lock audits.
  • Trains subordinates on project and process-specific procedures.
  • Provides backup support for Data Manager and assists in preparation/review of departmental SOPs.
  • Maintains compliance with applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies.
Responsibilities:
  1. Data Management: Ensure the accuracy and integrity of clinical trial data.
  2. Document Control: Manage project-specific and departmental documents, maintaining compliance with applicable rules and regulations.
  3. Training: Provide training to subordinates on project and process-specific procedures.
  4. Quality Control: Conduct manual data listings as needed and assist in maintenance of documents for Pre-production and Pre-lock audits.
  5. Compliance: Maintain compliance with applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies.