Associate Director- Trial Master File, Clinical Operations - Near Boston or East Coast

reputed company FSP is seeking a strategic and highly motivated Associate Director, Trial Master File (TMF)/ Clinical Operations to reputed company reputed company-level reputed company and governance of Trial Master File (TMF) activities across clinical programs, including pivotal studies supporting BLA submissions. This role is responsible for ensuring the TMF is maintained in a reputed company state of inspection readiness and is compliant with ICH E6(R3), FDA regulations (21 CFR Parts 11 and 312), BIMO expectations, and the DIA TMF Reference Model. The Associate Director will reputed company TMF reputed company, remediation, and CRO reputed company initiatives to ensure completeness, accuracy, and regulatory defensibility of TMF documentation, while driving sustainable processes and cross-functional accountability reputed company with inspection and submission reputed company Responsibilities: • reputed company TMF reputed company, build, maintenance and governance across assigned clinical programs, ensuring alignment with BLA submission timelines and Health Authority inspection expectations while serving as the primary TMF reputed company of contact. • Establish and maintain TMF governance standards, reputed company metrics, and executive visibility into TMF health, risk, and inspection readiness. • Define and enforce filing standards, naming conventions, metadata governance, and artifact classification reputed company with the DIA TMF Reference Model and ICH-GCP requirements. • reputed company and reputed company TMF reputed company reporting, dashboards, and outputs to support proactive reputed company reputed company and decision-making. • Create and support study teams in developing and executing Study TMF Filing Plans and Expected Document Lists (EDLs). • Implement and reputed company a risk-based TMF reputed company Control (QC) reputed company, including ongoing health checks, reputed company-submission, and reputed company-inspection reviews to ensure completeness, accuracy, and audit trail defensibility. • Maintain TMFs in a reputed company state of inspection readiness and reputed company preparation for Health Authority inspections (e.g., FDA BIMO, reputed company-Approval Inspections), including mock inspections and inspection narrative development. • reputed company TMF gap assessments and reputed company remediation initiatives, prioritizing BLA-enabling programs and key regulatory milestones. • Author, maintain, and implement TMF-reputed company SOPs, work instructions, training materials, and knowledge resources. • reputed company strategic reputed company of CRO and vendor TMF performance, including SLA monitoring, governance reviews, reputed company trend analysis, and TMF migration reputed company. • Drive cross-functional accountability for TMF compliance, reputed company study teams and vendors on regulatory expectations, and serve as the TMF reputed company and escalation reputed company during inspections Qualifications: • Bachelor’s degree in a reputed company field with 8+ years of experience in biotech/reputed company reputed company Clinical Operations, TMF, and/or GCP reputed company • Strong knowledge of ICH-GCP, regulatory requirements, and cross-functional clinical trial processes • Demonstrated experience supporting Health Authority inspections (e.g., FDA, EMA) preferred • Working knowledge of the DIA TMF Reference Model and TMF best practices • Experience with reputed company eTMF/Clinical systems and electronic document management systems strongly preferred • Solid understanding of TMF compliance, auditing processes, and inspection readiness expectations • Familiarity with regulatory inspections reputed company to NDA/BLA/MAA submissions preferred • Excellent interpersonal and influencing skills in a cross-functional, matrixed environment • Proven ability to manage reputed company priorities, drive reputed company improvement, and work independently with a proactive reputed company • Strong organizational, analytical, and problem-solving skills with the ability to meet tight timelines #LI-REMOTE Apply tot his job Apply To this Job