Trial Master File (TMF) Manager
Alto Neuroscience
This job is no longer accepting applications
See open jobs at Alto Neuroscience.See open jobs similar to "Trial Master File (TMF) Manager" Able Partners.The Trial Master File (TMF) Manager is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations, and Alto’s Standard Operating Procedures (SOPs). The TMF Specialist will oversee TMF health by conducting TMF Reviews and ensuring documents are maintained in the TMF and filed according to the TMF Reference Model. The TMF Specialist will serve as the subject matter expert (SME) on TMF set-up, maintenance, and archival, advising and guiding clinical study teams on management of eTMF. This role will be responsible for day-to-day TMF activities and TMF oversight.
Duties & Responsibilities
- Lead configuration, validation, and ongoing management of Alto’s eTMF system to ensure compliance and usability.
- Support development and implementation of TMF processes, including SOPs, templates, tools, training, and best practices.
- Collect, review, classify, and upload essential documents from internal and external sources into the eTMF.
- Conduct quality control (QC) reviews and monitor TMF health status across all clinical studies.
- Develop and maintain TMF completeness and compliance metrics; identify trends and recommend corrective actions or training.
- Ensure inspection readiness by adhering to documentation timelines and resolving TMF discrepancies, missing content, and expired documents.
- Collaborate cross-functionally to stay informed of study activities and documentation requirements.
- Provide and manage eTMF access for study team members, both internal and external.
- Support integration and migration of legacy or third-party TMFs.
- Use audit and QC findings to identify process gaps and drive continuous improvement across TMF operations.
LOCATION: Remote
SALARY RANGE: $98,000-120,000/year
Qualifications
- Bachelor’s degree (BS/BA) or equivalent training and experience.
- 3–5 years of experience in biotech, pharma, CRO, or TMF/document management settings.
- Strong knowledge of TMF operations, including the TMF Reference Model, ALCOA+ principles, Good Documentation Practices, and regulatory guidelines (ICH-GCP, FDA, EMA, PMDA).
- Solid understanding of clinical trial operations, including study/site management and trial planning.
- Proven ability to work independently and collaboratively in a fast-paced, matrixed environment with shifting priorities.
- Excellent communication, organization, and time management skills; able to manage multiple projects with high attention to detail.
- Strong analytical and critical thinking skills with a practical, solution-oriented mindset and tolerance for ambiguity.
Alto Neuroscience is an equal-opportunity employer that does not discriminate on the basis of sex, age, race, color, religion, marital status, sexual orientation, gender identity, pregnancy, disability, or any other characteristic protected by law. We offer a welcoming and inclusive environment in service to one another, our products, the diverse consumers we represent, and the communities we call home. We do all of this with kindness, empathy and respect for each other. The above is intended to describe the general content of and requirements for the performance of this job. It should not be construed as an exhaustive statement of duties, responsibilities or physical requirements.
This job is no longer accepting applications
See open jobs at Alto Neuroscience.See open jobs similar to "Trial Master File (TMF) Manager" Able Partners.