TMF Manager

TMF Manager Philadelphia, PA Job Details 1 day ago Benefits Stock options Health insurance Paid time off Qualifications Performance dashboards Stakeholder engagement Strategic management Document review (document control) Vendor management Startup experience 5 years Regulatory compliance Internal compliance auditing Risk mitigation strategy implementation Change management Team development Quality assurance audits ICH guidelines Project management Bachelor's degree Team management Mentoring Research compliance clinical trial records management Document archiving Good Clinical Practice Productivity software Quality audits Training & development Senior level Training Cross-functional collaboration Escalation handling Communication skills Regulatory compliance management Cross-functional communication Data extraction Stakeholder management Full Job Description About the Position This role can be remote, hybrid or based in our Philadelphia, PA headquarters. Reporting to the Senior Director, GCP Quality & Compliance, the TMF Manager is a key leader within the Quality and Compliance organization. This role has overall accountability for the strategic oversight, lifecycle management, and inspection readiness of the Trial Master File (TMF) across all clinical trials. The TMF Manager ensures trial documentation quality, completeness, consistency, and timeliness in alignment with ICH GCP, regulatory authority expectations, company SOPs, and the TMF Reference Model. The TMF Manager serves as a subject matter expert (SME) for TMF and eTMF processes, partners cross-functionally with Clinical Operations, Clinical Development, Regulatory, and external vendors, and provides leadership, guidance, and escalation management for TMF-related risks and issues across programs. Responsibilities Include TMF Oversight and Governance Provide strategic oversight of TMF management across all studies, ensuring inspection readiness at all times Establish and maintain study level TMF plans, master lists, and expected document lists in alignment with the TMF Reference Model Ensure adherence to ICH/GCP guidelines, regulatory requirements, and company policies related to TMF completeness and accuracy Oversee study start up, maintenance, close out, and archival readiness for all assigned trials Quality and Compliance Lead and oversee risk based TMF quality and completeness reviews using metrics, dashboards, and reports Identify, trend, and escalate TMF quality issues, risks, and non compliance to management with proposed mitigation strategies Ensure timely resolution of overdue, missing, or incorrect TMF documents Support internal audits, vendor audits, inspections, and health authority requests related to TMF eTMF System and Process Management Act as TMF/eTMF Subject Matter Expert across therapeutic areas and research phases Partner with system owners and vendors to support eTMF enhancements, implementations, and change initiatives Oversee complex TMF data extracts, exports, health authority requests, and divestiture support Ensure proper archival, long term storage, and retention of clinical trial documentation Leadership and Cross Functional Collaboration Provide functional guidance, training, and mentoring to TMF contributors and study teams Partner with CROs, Clinical Operations, study teams, and vendors to ensure clear TMF roles, responsibilities, and expectations and to promote TMF best practices Serve as the primary TMF point of contact for CROs, supporting oversight, issue resolution, and escalation management Support change management initiatives to drive TMF process efficiency and inspection readiness Leverage strong influencing and communication skills to align stakeholders and resolve issues Required Qualifications Bachelor's degree in a scientific or related discipline required. Minimum of 5 years of TMF experience, including study start-up, maintenance, closeout, and quality/completeness review. Experience in clinical trial-related roles (e.g., Clinical Operations, Project Management); demonstrated ability to manage multiple projects in a fast-paced environment and meet tight timelines. Strong knowledge and application of ALCOA+ principles, Good Clinical Practice (GCP), Good Documentation Practices (GDP), and ICH E6(R2) guidelines. Subject matter expertise in clinical trial documentation, TMF Reference Model, and associated processes and terminology. Knowledge of core, country, and site-level essential documents. Proficiency in eTMF systems and Microsoft Office tools. Strong critical thinking skills, with the ability to analyze and evaluate information to support quality review and decision-making. Excellent verbal and written communication and interpersonal skills. Collaborative team orientation with a commitment to continuous learning and development. Experience in industry, preferably within a startup environment. How to Apply Please click the link at the bottom of the posting to submit an application. Benefits Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans. Equal Opportunity Employer Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.