Trial Master File (TMF) Senior Specialist

About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”

If this sounds like you, keep reading!

Role Summary

We are seeking a Trial Master File (TMF) Senior Specialist to be responsible for the day-to-day management of TMF records for their respective studies, including upload, review, and approval. This role will help to ensure that studies are inspection ready by confirming that study records are filed in a timely manner, meet all applicable quality standards, and adhere to ICH-GCP guidelines, other regulatory requirements, and internal and external Standard Operating Procedures (SOPs).

Key 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.

Ideal Candidate

• 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; experience in Veeva Vault eTMF system is highly preferred.
• 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.
• Position requires up to 10% travel to All Hands company meetings and functional meetings.

The anticipated salary range for candidates for this role will be $110,000 - $140,000 year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

What We Offer

Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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