Contractor, Trial Master File Administrator

Syndax Pharmaceuticals is looking for a Trial Master File (TMF) Administrator.

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies.

The Role: 

Trial Master File (TMF) Administrator to be responsible for the oversight and management of the TMF for Syndax sponsored studies and for providing necessary support for clinical trials within Clinical Operations. This includes providing subject matter expertise on the Veeva Vault platform and Clinical Operations Team support required to ensure the TMF is inspection ready and adheres to ICH-GCP guidelines, other regulatory requirements, and internal and external Standard Operating Procedures (SOPs).  The candidate will also provide clinical trial support as needed for one or more clinical trials.  This role and responsibilities are pivotal to Clin Ops'success as the point of contact to the Clin Ops team, cross functional colleagues and external service providers used. used.

Key Responsibilities:

• Act as the single-point-of-contact at Syndax for all eTMFs.
• Monitor the status of the TMF for company sponsored studies.
• Conduct quality reviews of TMF records using the established TMF specifications, ICH-GCP guidelines, regulatory requirements, and applicable SOPs.
• Define and provide KPI metrics to internal and external stakeholders.
• Train internal and external stakeholders on relevant aspects of the Veeva Vault eTMF system i.e. CTMS, Site Connect etc.
• Ensure study team(s) are appropriately assigned eTMF User roles and permissions.
• Ensure compliant user onboarding, regular review, and offboarding.
• Review and contribute to study-specific TMF plans, TMF indices, and Expected Document Lists (EDLs) and identify when amendments and/or changes are needed.
• Collaborate with cross-functional teams to identify opportunities for improvement, advancement and development of the TMF Culture at Syndax through periodic functional TMF reviews.
• Remediate completeness review findings and assist with query management.
• Oversee / upload, classify, and index TMF records in the eTMF system.
• Ensure the eTMF is maintained with an audit-ready strategy and assist with inspection/audit-related activities (e.g., preparation, corrective actions). Ensure document quality and compliance through active engagement with clinical study teams.
• Help plan, organize, attend and take meeting minutes for clinical trial working groups.
• Perform reviews of essential documents and essential document packages in support of site activation.
• Lead periodic file completeness review throughout the life of the assigned studies.
• Liaise with cross functional clinical trial partners such as legal, regulatory and clinical supply.
• Maintain up-to-date knowledge of the TMF Reference Model, industry best practices, and regulatory requirements.

Desired Experience/Education and Personal Attributes:

• Minimum B.A./B.S. degree in science/healthcare field.
• 5 years of overall relevant clinical operations experience at a biotechnology, pharmaceutical, CRO, or TMF vendor.
• 3 years of experience working in an eTMF system; experience in Veeva Vault eTMF system is highly preferred.
• Experience in review and processing of clinical trial-related records required.
• Strong knowledge of Trial Master File (TMF) Reference Model.
• Demonstrated ability to understand and comply with ICH-GCP guidelines, and Good Documentation Practices.
• Strong organizational skills with outstanding attention to detail and follow-through.
• Demonstrated effective communication skills with internal and external team members.
• Highly conscientious.
• Must be resourceful and adaptable to effectively support multiple competing demands and changing priorities.
• Demonstrated ability to achieve high-performance goals and meet deadlines in a fast-paced environment.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Understanding of the clinical trial lifecycle.
• Must be fully proficient in MS Office Suite, Veeva, and familiar with Smartsheet and SharePoint.
• Position requires up to 5% travel to company meetings.

Location: While our corporate headquarters are located in New York City, this position is open to candidates from any location with a preference for east coast locations.  

About Syndax:
Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.

#LI-Remote

Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.