eTMF Operations Specialist

Alkeus Pharmaceuticals; Cambridge (MA); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical/dental/vision insurance plans

401(K) plan

Flexible time off

Job summary

Alkeus Pharmaceuticals, Inc. in Cambridge, MA is seeking an Electronic Trial Master File (eTMF) Associate to support management, quality, completeness, and inspection readiness of the eTMF across clinical programs.

You will collaborate with study teams, CROs, and vendors to file documents accurately and on time per ICH-GCP and company procedures, while helping with TMF health checks, inspections, and CAPA-related activities.

Qualifications

• Bachelor’s degree or related field required.
• 1–3 years of clinical research or TMF-related experience.
• Experience with eTMF systems preferred.

Responsibilities

• Support eTMF deliverables throughout the study lifecycle.
• Review and file documents in eTMF locations per TMF Reference Model.
• Ensure documents are complete, version controlled, and contemporaneous.
• Monitor eTMF quality metrics and address filing gaps.
• Assist with inspection readiness activities and regulatory inspections.
• Support CAPA implementation related to TMF activities.
• Collaborate with trial managers, CROs, and vendors for documentation.

Skills

Entrepreneurial spirit

Highly organized

Detail oriented

Excellent communication

Team player

Fast-paced project management

Education

Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or related field

Tools

Veeva Vault eTMF

Trial Interactive

Wingspan

Florence

Job description

Alkeus Pharmaceuticals, Inc. in Cambridge, MA is seeking an Electronic Trial Master File (eTMF) Associate to support management, quality, completeness, and inspection readiness of the eTMF across clinical programs.

You will collaborate with study teams, CROs, and vendors to file documents accurately and on time per ICH-GCP and company procedures, while helping with TMF health checks, inspections, and CAPA-related activities.