eTMF Specialist - Remote

Overview

The eTMF Specialist will work across clinical study teams to manage TMF processes for clinical studies, ensuring compliance and quality throughout the study lifecycle.

In Short

• Assess eTMF metrics for completeness, timeliness, and quality.
• Facilitate TMF QC Reviews and track issues to resolution.
• Build partnerships with stakeholders for eTMF engagement.
• Engage with CROs/Vendors to define eTMF responsibilities.
• Contribute to eTMF study creation and maintenance.
• Apply risk-based quality management principles to TMF oversight.
• Identify business needs for eTMF process improvement.
• Participate in creating and reviewing Study-specific eTMF Plans.
• Engage in discussions with IT regarding eTMF systems.
• Participate in health authority inspections and audits.

Requirements

• 2-5 years of industry experience with TMF/eTMF.
• Hands-on experience with TMF QC processes.
• Knowledge of ICH-GCP, FDA, and EMA regulations.
• Working knowledge of the CDISC TMF Reference Model.
• Experience with Veeva Vault eTMF is a plus.
• Self-starter with critical thinking skills.
• Excellent organizational skills and ability to multitask.
• Outstanding verbal and written communication skills.
• Strong work ethic and attention to detail.

Benefits

• Collaborative work environment.
• Opportunity to impact drug discovery processes.
• Professional development opportunities.
• Work with a world-class team.
• Engagement in innovative projects.