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

We are seeking a Trial Master File Manager (TMF Manager) to be responsible for the day-to-day management of TMF files for their respective studies, including the upload, review, and approval of TMF documents. Co-authors and manages TMF documents such as TMF Plan, Index, SOPs, and other guidance documents. Ensuring quality management of their studies by reporting TMF metrics, periodic checks of adherence to SOPs, and reconciling all outstanding queries and issues e.g. CAPAs. Support the Associate Director in high-level projects, developing processes, and strategies and conducting training for TMF stakeholders. Responsible for overseeing the activities of the TMF Specialist and external vendors ensuring that study documents are performed with adherence to ICH-GCP guidelines, other regulatory requirements, and internal and external standard operating procedures (SOPs) and that their assigned studies are inspection-ready.

Key Responsibilities

• Management of clinical studies to ensure timely, consistent, and quality setup and maintenance of TMF requirements and processes. This includes document QC, upload, remediation, and query management
• Ensure that the staff is appropriately trained in systems, processes SOPs, and other onboarding activities for new staff
• Develop successful working relationships with TMF stakeholders, both internal and external, also includes overseeing the TMF Specialists and ensuring they meet study deliverables
• Responsible for risk mitigation, action plans, and issue resolution along with proactively communicating changes, updates, and issues to all TMF stakeholders
• Oversight of internal and external audits and inspection activities which includes oversight of the development and timely resolution of corrective action plans related to TMF findings
• Develop lessons learned and share across programs and foster a culture of constant improvement as a TMF ambassador
• Review data quality outputs and audit outputs to identify trends; develop process improvements, includes reviewing and reporting metrics established for performance TMF reviews and providing action plans as appropriate
• Attend/conduct study team and other meetings as needed
• Perform other duties as assigned such as supporting the Associate Director with projects, and initiatives, co-managing TMF education services, etc.

Ideal Candidate

• B.A./B.S. degree in science/healthcare field
• 9+ years of overall relevant clinical operations and TMF experience at a biotechnology, pharmaceutical, or TMF vendor
• 3+ years of experience working for a CRO supporting Clinical Operations
• 4+ years of experience working in eTMF system software; experience in Veeva Vault eTMF system software is highly preferred.
• Understanding of the clinical trial lifecycle
• Experience in handling clinical trial-related documents required
• Strong knowledge of Trial Master File Reference Model Structure standard and country-level documents
• Demonstrated ability to understand and comply with ALCOA+ standards, ICH-GCP guidelines, and Good Documentation Practices
• Demonstrated ability to achieve high-performance goals and meet deadlines in a fast-paced environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• Excellent organizational skills and possesses high standards and great attention to detail
• Strong communication skills – verbal and written
• 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
• Must be proficient in Microsoft Excel, Word, and PowerPoint, and familiar with Smartsheet and SharePoint
• Willingness to travel up to 10% including a minimum of 4 times per year for All Hands company meetings

The anticipated salary range for candidates for this role will be $140,000-$160,000/ 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

·       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 is a primarily remote company – we hold regular all team, in-person meetings to build relationships and problem solve

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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