eTMF Specialist: Clinical Trials & Compliance

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

Job summary

Alkeus Pharmaceuticals, Inc. is a Cambridge, MA-based clinical-stage biotech company focused on therapies for serious eye diseases.

The eTMF Associate supports management, quality, and inspection readiness of the electronic Trial Master File across development programs, collaborating with study teams, CROs, and vendors. The role ensures documents are complete, version controlled, and timely, adhering to ICH-GCP and company procedures while contributing to TMF health checks, CAPA, and training

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or related field, or an Associate degree with relevant experience.
• 1–3 years of experience in clinical research, document management, quality, or clinical operations.
• Experience with an eTMF system (e.g., Veeva Vault eTMF, Trial Interactive, Wingspan, Florence).
• Understanding of TMF structure and ICH-GCP requirements.
• Biotech/pharma/CRO experience preferred.

Responsibilities

• Manage eTMF deliverables across the study lifecycle.
• Review and file clinical trial documents in eTMF locations.
• Monitor TMF quality and completeness metrics.
• Support inspection readiness activities and regulatory inspections.
• Collaborate with Clinical Trial Managers, CROs, and vendors.
• Support study start-up, maintenance, and closeout documentation.
• Coordinate document collection and filing with CROs and vendors.

Skills

Entrepreneurial spirit

Highly organized

Communication skills

Attention to detail

Team player

Problem solving

Education

Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or related scientific discipline, or Associate degree + relevant experience.

Tools

eTMF systems (Veeva Vault eTMF, Trial Interactive, Wingspan, Florence)

Job description

Alkeus Pharmaceuticals, Inc. is a Cambridge, MA-based clinical-stage biotech company focused on therapies for serious eye diseases.

The eTMF Associate supports management, quality, and inspection readiness of the electronic Trial Master File across development programs, collaborating with study teams, CROs, and vendors. The role ensures documents are complete, version controlled, and timely, adhering to ICH-GCP and company procedures while contributing to TMF health checks, CAPA, and training