Lead Data Specialist

2 days ago

Vijayawada, Andhra Pradesh, India beBeeClinical Full time ₹ 12,00,000 - ₹ 15,00,000
Senior Data Operations Lead

We are seeking a highly skilled Senior Clinical Data Coordinator to join our team. This role is responsible for project-specific and departmental document tracking and control activities.

Key Responsibilities:

  • 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 to maintain data integrity.
  • Prepares project-specific documents, including Data Clarification Forms, to support clinical database updates.
  • Handles client and team requests/issues in coordination with the Project Manager.
  • C Coordinates User Acceptance Testing (UAT) with Clinical Data Associates to ensure robust database design.
  • Performs procedure verification as part of database validation to ensure data validity.
  • Creates, reviews, processes, and tracks Data Clarification Forms to update clinical databases.
  • Conducts manual data listings as needed to support data quality.
  • Maintains documentation for Pre-production and Pre-lock audits to ensure regulatory compliance.
  • Provides project and process specific training to subordinates.
  • Serves as a backup for the Data Manager.
  • Assists in preparing and reviewing departmental SOPs to ensure standard operating procedures.
  • Conducts basic QC functions for departmental activities to ensure data accuracy.
  • Ensures SOP compliance in project deliverables to meet regulatory requirements.
  • Adheres to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs), and policies to conduct delegated activities.

Requirements:

  • Bachelor's degree in Life Sciences or related field.
  • Minimum 5 years of experience in clinical data management.
  • Strong understanding of clinical trials and data management principles.
  • Excellent communication and interpersonal skills.
  • Able to work in a team environment and adapt to changing priorities.

What We Offer:

We offer a dynamic and supportive work environment, opportunities for professional growth and development, and a competitive compensation package.

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