eTMF & Quality Lead for Clinical Trials

Scorpion Therapeutics; Kennesaw (GA); On-site; USD 75,000 - 110,000; Full time

Job summary

Scorpion Therapeutics is seeking a Clinical eTMF Specialist to manage and ensure high-quality electronic Trial Master File across clinical trial lifecycles. You will coordinate TMF activities, perform quality checks and drive inspection readiness with cross-functional teams.

The role requires a Bachelor's in Life Sciences or related field, 2–4 years in TMF/eTMF management, and hands-on use of systems like Florence or Veeva Vault. Travel is required.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 2–4 years of clinical trial documentation and TMF/eTMF management experience.
• Strong knowledge of ICH-GCP, FDA, EMA.
• Hands-on with eTMF systems (e.g., Florence, Veeva Vault).
• Excellent organizational and communication skills; ability to travel.

Responsibilities

• Maintain compliance with GCP, ICH guidelines, SOPs, and regulations.
• Perform quality checks, monitor metrics, and address gaps.
• Collaborate with Clinical Operations, QA, Regulatory Affairs, CROs, and study sites.
• Support inspection readiness, audits, and system upgrades.
• Develop SOPs and training materials.

Skills

Organizational skills

Communication

Teamwork

Attention to detail

Education

Bachelor's degree in Life Sciences or related field

Tools

Florence

Veeva Vault

Job description

Scorpion Therapeutics is seeking a Clinical eTMF Specialist to manage and ensure high-quality electronic Trial Master File across clinical trial lifecycles. You will coordinate TMF activities, perform quality checks and drive inspection readiness with cross-functional teams.

The role requires a Bachelor's in Life Sciences or related field, 2–4 years in TMF/eTMF management, and hands-on use of systems like Florence or Veeva Vault. Travel is required.