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

Parexel FSP is seeking a strategic and highly motivated Associate Director, Trial Master File (TMF)/ Clinical Operations to provide enterprise-level oversight 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 continuous 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 lead TMF quality, remediation, and CRO oversight initiatives to ensure completeness, accuracy, and regulatory defensibility of TMF documentation, while driving sustainable processes and cross-functional accountability aligned with inspection and submission timeline •

Responsibilities:

•+ Lead TMF strategy, 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 point of contact. + Establish and maintain TMF governance standards, quality metrics, and executive visibility into TMF health, risk, and inspection readiness. + Define and enforce filing standards, naming conventions, metadata governance, and artifact classification aligned with the DIA TMF Reference Model and ICH-GCP requirements. + Develop and oversee TMF quality reporting, dashboards, and outputs to support proactive quality oversight and decision-making. + Create and support study teams in developing and executing Study TMF Filing Plans and Expected Document Lists (EDLs). + Implement and oversee a risk-based TMF Quality Control (QC) framework, including ongoing health checks, pre-submission, and pre-inspection reviews to ensure completeness, accuracy, and audit trail defensibility. + Maintain TMFs in a continuous state of inspection readiness and lead preparation for Health Authority inspections (e.g., FDA BIMO, Pre-Approval Inspections), including mock inspections and inspection narrative development. + Lead TMF gap assessments and structured remediation initiatives, prioritizing BLA-enabling programs and key regulatory milestones. + Author, maintain, and implement TMF-related SOPs, work instructions, training materials, and knowledge resources. + Provide strategic oversight of CRO and vendor TMF performance, including SLA monitoring, governance reviews, quality trend analysis, and TMF migration oversight. + Drive cross-functional accountability for TMF compliance, coach study teams and vendors on regulatory expectations, and serve as the TMF lead and escalation point during inspections •

Qualifications:

•+ Bachelor's degree in a related field with 8+ years of experience in biotech/pharma within Clinical Operations, TMF, and/or GCP Quality + 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 Veeva 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 related to

NDA/BLA/MAA

submissions preferred + Excellent interpersonal and influencing skills in a cross-functional, matrixed environment + Proven ability to manage complex priorities, drive continuous improvement, and work independently with a proactive mindset + Strong organizational, analytical, and problem-solving skills with the ability to meet tight timelines \#LI-REMOTEEEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.