Trial Master File Specialist

The Trial Master File (TMF) Specialist is an entry-level position within the Clinical Operations team at Neurotech Pharmaceuticals. This role offers an excellent opportunity for individuals with a strong educational foundation in life sciences or a related field to launch their career in clinical research and regulatory documentation.

The TMF Specialist will play a critical role in supporting the organization, review, and maintenance of essential clinical trial documents to ensure regulatory compliance and inspection readiness. Working under the direct supervision of the Vice President, Clinical Operations, the TMF Specialist will receive structured training and hands-on mentorship to build foundational knowledge of clinical trial documentation processes and regulatory standards.

This is a remote position.

Job Requirements

• Assist in the collection, organization, and quality review of essential clinical trial documents in alignment with ICH GCP, FDA regulations, and internal SOPs.
• Support the day-to-day management and maintenance of the Trial Master File (TMF) across all phases of clinical trial execution.
• Conduct document quality control checks to ensure accuracy, completeness, and compliance with study-specific and regulatory requirements.
• Participate in ongoing TMF health checks and support preparation activities for audits and regulatory inspections.
• Assist with tracking TMF metrics and key performance indicators (KPIs) related to document quality and timeliness.
• Help coordinate trial-related team meetings, including drafting agendas, taking minutes, and following up on action items.
• Collaborate with internal teams, clinical sites, and external vendors to resolve TMF document queries or gaps.
• Support ad hoc administrative and operational activities within Clinical Operations as needed, including document archiving, site start-up tracking, and study status reporting.

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field is preferred.
• No prior TMF or clinical research experience required-full training will be provided.
• Strong organizational skills and keen attention to detail.
• Ability to manage multiple priorities and meet timelines in a dynamic, fast-paced environment.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) and willingness to learn document management systems and clinical trial software platforms.
• A team player mindset, with the ability to work collaboratively across departments and with external stakeholders.
• Familiarity with clinical research terminology, regulatory processes, or coursework in clinical research, biology, or healthcare.
• Exposure to electronic document management systems (e.g., eTMF platforms, SharePoint) is a plus.

Up to 10% domestic and international travel as needed for company meetings and/or investigator meetings

Neurotech Pharmaceuticals, Inc. is a private biotech company located in Cumberland, RI and Needham, MA, within the realm of Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, our focus has been on developing and commercializing transformative therapies for chronic eye diseases. The core platform technology, Encapsulated Cell Therapy (ECT), is a first-in-class drug delivery platform designed to slow the progression of chronic eye diseases. Neurotech’s first commercial product, ENCELTOTM (revakinagene taroretcel-lwey), is approved in the United States for the treatment of adults with idiopathic Macular Telangiectasia Type 2 (MacTel). Encapsulated cell-based gene therapy is designed to provide long-term, sustained delivery of therapeutic proteins for the treatment of chronic eye diseases.