Electronic Trial Master File (eTMF) Associate

About the role

Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001).

Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S.

Position Summary

The eTMF Associate is responsible for supporting the management, quality, completeness, and inspection readiness of the electronic Trial Master File (eTMF) across clinical development programs. This role collaborates with internal study teams, CROs, and vendors to ensure essential clinical trial documentation is filed accurately, timely, and in accordance with ICH-GCP, regulatory requirements, and company procedures.

Primary Responsibilities

• eTMF Management
• Support eTMF deliverables throughout the study lifecycle, from study start-up through closeout.
• Review and file clinical trial documents in the appropriate eTMF locations in accordance with the TMF Reference Model.
• Ensure documents are complete, accurate, version controlled, and contemporaneous.
• Monitor eTMF quality and completeness metrics and address filing gaps.
• Inspection Readiness
• Support ongoing TMF health checks and quality reviews.
• Assist with inspection-readiness activities and preparation for regulatory inspections and audits.
• Support tracking and resolution of TMF findings, quality issues, and overdue documents.
• Support CAPA implementation related to TMF activities as applicable.
• Clinical Operations Support
• Collaborate with Clinical Trial Managers, Clinical Study Associates, CROs, and vendors to obtain required documentation.
• Support study start-up, maintenance, and closeout documentation activities.
• Participate in study team meetings and provide TMF status updates.
• Assist with the tracking of essential documents, training records, and study-specific deliverables.
• Vendor and CRO Collaboration
• Coordinate document collection and filing activities with CROs and external vendors.
• Ensure vendor-generated documentation is received and filed according to established timelines.
• Support reconciliation activities between the CRO TMF and sponsor eTMF.
• Process Improvement and Compliance
• Follow company SOPs, work instructions, and regulatory requirements.
• Contribute to the development and improvement of TMF processes and tools.
• Support TMF-related training activities for internal and external stakeholders.
• Assist with document migration, archival, and system-related initiatives as needed.
• Deliver on other related projects as assigned.

Qualifications

• Education and Certification
• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Public Health, or related scientific discipline, or Associate degree + relevant experience.
• Work Experience
• 1-3 years of experience in clinical research, document management, quality, or clinical operations.
• Experience working with an eTMF system preferred (e.g., Veeva Vault eTMF, Trial Interactive, Wingspan, Florence, or equivalent).
• Understanding of the Trial Master File structure and ICH-GCP requirements.
• Biotech, pharmaceutical, or CRO experience preferred.
• Skills and Key Success Factors
• Entrepreneurial spirit with a passion to build, learn and evolve with the team
• Highly organized and detail oriented with a passion to deliver quality results
• Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
• Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
• Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
• Evidence of "hands-on" experience and expertise
• Proven and successful track record as a team-player and collaborator in small working environments
• Highest levels of professionalism, confidence, personal values and ethical standards

Other Relevant Information

• Travel: able to travel globally up to 20% of time

Compensation

• Base Salary Range: $55,000 - $75,000, with the actual contingent upon several factors such as the selected candidate's education/work experience/training, and other factors (travel requirements, etc.)
• Discretionary Bonus: up to 5% of Base Salary, contingent upon meeting performance components
• Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.