Trial Master File Senior Specialist

Summary

Join Apogee Therapeutics as a Trial Master File (TMF) Senior Specialist and manage the day-to-day TMF records for assigned studies. You will ensure studies are inspection-ready by confirming timely filing, adherence to quality standards, and compliance with regulations. Key responsibilities include quality reviews, plan review, remediation, record management in the eTMF system, and participation in team meetings and audits. The ideal candidate possesses a B.A./B.S. degree in a science/healthcare field, 3-5 years of relevant experience (including 2+ years in an eTMF system), and strong knowledge of TMF, ALCOA+, ICH-GCP, and Good Documentation Practices. Apogee offers a competitive compensation and benefits package, including a base salary, performance bonus, equity grants, health, welfare, and retirement benefits, flexible PTO, and professional development opportunities.

Requirements

• Minimum B.A./B.S. degree in science/healthcare field
• 3-5 years of overall relevant clinical operations experience at a biotechnology, pharmaceutical, CRO, or TMF vendor, including: 2+ years of experience working in an eTMF system
• Must be fully proficient in MS Office Suite, and familiar with Smartsheet and SharePoint
• Understanding of the clinical trial lifecycle
• Experience in handling clinical trial-related records required
• Strong knowledge of Trial Master File (TMF) Reference Model
• Demonstrated ability to understand and comply with ALCOA+ standards, ICH-GCP guidelines, and Good Documentation Practices
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• 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

Responsibilities

• Conduct quality reviews of TMF records using the established TMF specifications, ICH-GCP guidelines, ALCOA++, regulatory requirements, and applicable SOPs
• Review study-specific TMF plans, TMF indices, and Expected Document Lists (EDLs) for their respective studies
• Remediate completeness review findings and assist with query management
• Upload, classify, and index TMF records in the eTMF system
• Attend study team meetings, as needed
• Assist with inspection/audit-related activities (e.g., preparation, corrective actions)
• Maintain up-to-date knowledge of the TMF Reference Model, industry best practices, and regulatory requirements
• Perform other duties as assigned such as reviewing TMF guidance documents and training and supporting the TMF team in various activities

Preferred Qualifications

Experience in Veeva Vault eTMF system is highly preferred

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient and E goless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve