Clinical Data Management Specialist

1 week ago

Hyderabad, Telangana, India beBeeClinicalDataCoordinator Full time ₹ 10,00,000 - ₹ 20,00,000

**Job Overview:**

We are seeking a skilled Clinical Data Coordinator to join our team. In this role, you will be responsible for managing and tracking project-specific documents, reviewing CRFs, and preparing project documents.

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  • Responsible for project management and coordination activities including document control, review, and preparation.
  • Reviews CRF (as per protocol) and project-specific documents to ensure compliance and accuracy.
  • Responsible for initiating and maintaining project DMTMF and e-filing processes.
  • Prepares project-specific documents and ensures timely delivery.
  • Handles requests and issues from clients and teams in collaboration with the Project Manager.
  • Coordinates with CDA for User Acceptance Testing (UAT) to ensure robust database design.
  • Verifies procedures as part of database validation.
  • Creates, reviews, processes, and tracks Data Clarification Forms and updates clinical databases for data validity.
  • Conducts manual data listings as needed.
  • Supports maintenance of documents for Pre-production and Pre-lock audits.
  • Provides training for subordinates on project and process specifics.
  • Serves as backup for Data Manager.
  • Assists in preparation and review of departmental SOPs.
  • Performs basic quality control functions for departmental activities.
  • Ensures SOP compliance in project deliverables.
  • Other responsibilities may include tasks delegated by reporting head and senior management.
  • Ensures compliance with applicable rules, regulations, guidelines, SOPs, work instructions, and policies.

Requirements:

The ideal candidate will have strong organizational skills, attention to detail, and excellent communication skills. A bachelor's degree in a related field is required, and experience in clinical data management is an asset.

Benefits:

This role offers competitive compensation and benefits, opportunities for professional growth and development, and a dynamic work environment.

What We Offer:

Our company provides a supportive and inclusive workplace culture, with access to ongoing training and development programs, flexible work arrangements, and recognition for outstanding performance.

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