TMF (Trial Master File) Manager

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

The Trial Master File (TMF) Manager is responsible for the day-to-day management and oversight of the TMF for their respective studies. This role acts as the main point of contact and TMF Subject Matter Expert (SME) on the study team for their respective studies. This role collaborates cross-functionally to co-author and manage study-specific TMF management documents such as TMF Plan, TMF Index, and EDLs. This role is responsible for quality management and ensuring that their respective studies remain inspection ready through monitoring and reporting of TMF health metrics to assess TMF quality, completeness and timeliness, confirming adherence to SOPs, providing oversight and assistance with completeness reviews, and reconciling all outstanding queries and issues (e.g. CAPAs). This role is responsible for overseeing the activities of the TMF Specialists and external vendors.

Key Responsibilities

• Responsible for the end-to-end management, quality, compliance, and inspection readiness of the TMF for their respective studies from setup through archival in accordance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and regulatory requirements.
• Provide support, guidance, and collaborate cross functionally with the study team and CRO to ensure the accuracy, completeness, quality, and timeliness of the TMF.
• Provide direction and training to the study team and external stakeholders (CROs, vendors) on the eTMF system, TMF processes, SOPs, regulatory requirements, and best practices.
• Develop successful working relationships with TMF stakeholders, both internal and external, also includes overseeing the TMF Specialists and ensuring they meet study deliverables.
• Develop and maintain study-specific TMF plans, TMF indexes, and Expected Document Lists (EDLs) for their respective studies, working both cross-functionally and with CROs.
• Setup and maintain the study in the eTMF and manage user access to ensure proper permissions and system security.
• Lead and facilitate storyboarding to ensure the TMF reflects the study accurately and that actions, decisions, and challenges are adequately accounted for.
• Support study team and CRO team members with the completion of periodic TMF completeness reviews. Ensure reviews are conducted in accordance with SOPs and the study-specific TMF Plan and that all issues identified are resolved in a timely manner.
• Upload records, perform QC and remediation, and drive query management, as needed.
• Track study KPIs, generate regular TMF status reports, including metrics on TMF completeness, quality, and timelines, and report metrics to the study team and TMF Management Leadership. Drive actions when issues or negative trends are identified.
• Attend study team meetings and provide updates or reminders surrounding TMF activities (e.g. communicating metrics, issues, trends, or process changes).
• Support internal and external audits and inspection activities, including preparation, conduct, and oversight of the development and timely resolution of corrective action plans related to TMF findings.
• Perform risk-based quality checks of TMF records to confirm quality and adherence to process. Ensure issues identified are resolved in a timely manner.
• Responsible for risk mitigation, action plans, and issue resolution along with proactively communicating changes, updates, and issues to all TMF stakeholders.
• Develop lessons learned and share across programs and foster a culture of constant improvement as a TMF ambassador.
• Support system updates by participating in user acceptance testing and system enhancement discussions.
• Maintain up-to-date knowledge of the TMF Reference Model, industry best practices, and regulatory requirements.
• Perform other duties as assigned such as supporting TMF Management Leadership with projects and initiatives.

Ideal Candidate

• A./B.S. degree in science/healthcare field.
• 8-10 years of overall relevant clinical operations experience at a biotechnology, pharmaceutical, CRO, or TMF vendor
  • 7+ years of experience working in TMF management and eTMF system; experience in Veeva Vault eTMF system software is highly preferred.
• Must be proficient in Microsoft Excel, Word, and PowerPoint, and familiar with Smartsheet and SharePoint
• Understanding of the clinical trial lifecycle.
• Experience in management of 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.
• Excellent organizational skills with outstanding attention to detail and follow through.
• Demonstrated effective verbal and written communication skills with internal and external team members.
• Highly conscientious and takes initiative to efficiently resolve issues.
• Must be resourceful and adaptable to support multiple competing demands and changing priorities.
• Proven successes in problem-solving, strong decision-making, critical thinking, and conflict management.
• 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 $125,000-$150,000/ 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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