Tmf Manager

Summary

Join Apogee Therapeutics as a Trial Master File (TMF) Manager and oversee the day-to-day management of TMFs for various studies. You will act as the main point of contact and subject matter expert, collaborating cross-functionally to manage TMF documents and ensure inspection readiness. Responsibilities include quality management, monitoring TMF health metrics, overseeing TMF specialists, and collaborating with CROs. You will also develop and maintain TMF plans and indexes, manage the eTMF system, and support study teams with completeness reviews. The role requires strong knowledge of TMF processes, regulatory requirements, and ALCOA+ standards. This position offers a competitive compensation and benefits package, including flexible PTO and opportunities for professional development.

Requirements

• 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
• 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

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

Preferred Qualifications

Experience in Veeva Vault eTMF system software 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