Lead Clinical Data Specialist

3 days ago

Coimbatore, Tamil Nadu, India beBeeClinicalDataCoordinator Full time ₹ 8,00,000 - ₹ 10,00,000

Job Opportunity:

We are seeking a highly skilled Clinical Data Coordinator to lead our clinical data management activities. In this role, you will be responsible for ensuring the accuracy and integrity of data, collaborating with cross-functional teams, and driving project success.

Key Responsibilities:

  • Document tracking: You will be responsible for project-specific and departmental document tracking and control activities
  • CRF reviews: Reviews CRF (as per protocol) and project-specific documents
  • Data Management Trial Master File (DMTMF): Responsible for initiating project-specific DMTMF and e-filing and reviewing it on an ongoing basis
  • Document preparation: Responsible for preparing project-specific documents
  • User Acceptance Testing (UAT): Coordinates with CDA in UAT leading to robust database design
  • Procedure verification: Performs procedure verification as a part of database validation
  • Data Clarification Forms: Responsible for creating, reviewing, processing and tracking of Data Clarification Forms and updating clinical databases for ensuring data validity as per the protocol
  • Manual data listings: Conducts manual data listings as needed
  • Document maintenance: Assist in maintenance of the documents for Pre-production and Pre-lock audits
  • Training: Conducts project and process specific training for subordinates
  • Backup support: Acting as a back-up for Data Manager
  • SOP preparation/review: Assists in preparation/ review of departmental SOPs
  • Basic QC functions: Conducts basic QC functions for departmental activities
  • SOP compliance: Ensures SOP compliance in project deliverables
  • Ongoing responsibilities: Other responsibilities as delegated by reporting head & senior management
  • Compliance: Ensure compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies etc. for conducting delegated activities

About Us:

We are a leading technology company dedicated to delivering innovative solutions. We are passionate about making a difference in people's lives through technology.

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