Clinical Coordinator

Hello,

If you have minimum 1 years experience in ETMF means pls share your resume with [Confidential Information] with below details.

Name;

Email;

Ph;

Notice period;

CCTC;

ECTC;

Current location;

Willing to attend face to face interview;

Role Overview

The TMF Coordinator will support the preparation, quality review, management, and maintenance of Trial Master File (TMF) documentation to ensure inspection readiness and compliance with regulatory requirements. The role involves working closely with clinical study teams and managing documentation within eTMF systems.

Key Responsibilities

• Perform pre-QC of study documents before upload into the eTMF system.
• Upload, name, index, and maintain clinical trial documentation.
• Support management and maintenance of study-specific TMF records.
• Ensure TMF documents are complete, accurate, and inspection-ready.
• Maintain and update Electronic Document Lists (EDL).
• Manage TMF records within eTMF platforms such as Veeva Vault.
• Conduct periodic TMF quality checks and identify documentation gaps.
• Coordinate with study teams to resolve documentation queries.
• Ensure compliance with ICH-GCP guidelines and the DIA TMF Reference Model.
• Support audit and regulatory inspection readiness activities.

Required Qualifications & Experience

• Bachelor's degree in Life Sciences, Pharmacy, Healthcare, or a related field.
• Minimum 1 year of experience in Clinical Operations, Clinical Documentation, or TMF/eTMF management.
• Good understanding of clinical trial documentation.
• Knowledge of ICH-GCP guidelines and regulatory requirements.
• Strong communication and documentation skills.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).

Preferred Experience

• Hands-on experience with Veeva Vault or similar eTMF platforms.
• Familiarity with the DIA TMF Reference Model.
• Experience in clinical trial document management and inspection readiness.
• Exposure to eCTD binders and CSR appendices.