Senior Clinical Data Governance Specialist

1 day ago

Thiruvananthapuram, Kerala, India beBeeClinical Full time ₹ 9,62,400 - ₹ 12,18,000

Senior Clinical Data Coordinator Job Description

As a Senior Clinical Data Coordinator, you will play a pivotal role in ensuring the integrity and accuracy of clinical data. Your responsibilities will include:

Key Responsibilities
  • Document Control: Oversee project-specific and departmental document tracking and control activities to maintain compliance and efficiency.
  • CRF Review: Thoroughly review CRFs (as per protocol) and project-specific documents to ensure accuracy and consistency.
  • Data Management: Initiate and manage project-specific DMTMF (Data Management Trial Master File) and e-filing, conducting regular reviews to ensure ongoing compliance.
  • Document Preparation: Prepare project-specific documents, including reports and other materials, as required.
  • Client Support: Handle client and team requests/issues in coordination with Project Managers, providing timely solutions and support.
  • Database Design: Collaborate with CDA on User Acceptance Testing (UAT) to ensure robust database design and implementation.
  • Procedure Verification: Perform procedure verification as part of database validation to guarantee accuracy and reliability.
  • Data Clarification Forms: Create, review, process, and track Data Clarification Forms, updating clinical databases to ensure data validity.
  • Manual Data Listings: Conduct manual data listings as needed to ensure accurate data collection and reporting.
  • Training and Development: Provide training for subordinates on project and process-specific procedures.
  • Backup Support: Act as a backup for the Data Manager, providing support and coverage as needed.

To be successful in this role, you must possess excellent organizational and communication skills, with the ability to work effectively in a fast-paced environment. You will also need to ensure SOP compliance in project deliverables and adhere to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs), and policies.

Required Skills and Qualifications

  • Excellent organizational and communication skills.
  • Able to work effectively in a fast-paced environment.
  • Ability to ensure SOP compliance in project deliverables.

Benefits

This role offers the opportunity to work in a dynamic and challenging environment, where you will have the chance to develop your skills and expertise. You will be working as part of a talented team, contributing to the success of our organization.

Others

Please note that we are an equal opportunities employer and welcome applications from all qualified candidates.

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