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Clinical Data Operations Lead

2 weeks ago


Lucknow, Uttar Pradesh, India beBeeClinicalCoordinator Full time ₹ 10,00,000 - ₹ 15,00,000
Senior Clinical Data Coordinator Job

We are seeking a skilled Senior Clinical Data Coordinator to fill this role.

About the Role:

  • The ideal candidate will have strong project management skills and be able to coordinate with cross-functional teams.
  • They will also have experience working with clinical data and be proficient in database design.

Main Responsibilities:

  1. Document Tracking: The coordinator will be responsible for tracking and managing project-specific documents.
  2. CRF Review: They will review CRFs (as per protocol) and project-specific documents.
  3. Data Management: The coordinator will manage project-specific DMTMF (Data Management Trial Master File) and e-filing.
  4. Document Preparation: They will prepare project-specific documents.
  5. Client Coordination: The coordinator will handle requests/issues by the client and team, in coordination with PM.
  6. Database Design: They will coordinate with CDA in User Acceptance Testing (UAT) leading to robust database design.
  7. Procedure Verification: The coordinator will perform procedure verification as a part of database validation.
  8. Data Clarification Forms: They will create, review, process, and track Data Clarification Forms and update clinical databases for ensuring data validity as per the protocol.
  9. Manual Data Listings: The coordinator will conduct manual data listings as needed.
  10. Training and Development: They will assist in maintenance of the documents for Pre-production and Pre-lock audits and conduct project and process-specific training for subordinates.
  11. Backup Support: The coordinator will act as a back-up for Data Manager.
  12. SOP Compliance: They will assist in preparation/review of departmental SOPs and ensure SOP compliance in project deliverables.
  13. Quality Control: The coordinator will conduct basic QC functions for departmental activities.
  14. Compliance: They will ensure compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies etc. for conducting delegated activities.

Requirements:

  • Bachelor's degree in a relevant field.
  • Minimum 3 years of experience in clinical data coordination or a related field.
  • Strong communication and organizational skills.
  • Ability to work effectively in a team environment.

Benefits:

  • A competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and supportive work environment.