Associate Director, TMF Operations

Salary: $184-$210k + bonus + options + benefits Hybrid role — 2-3 days in Needham office Position Summary: We’re looking for an experienced Associate Director, Trial Master File (TMF) Operations to lead the Trial Master File operations across our oncology clinical programs. This role is ideal for someone who enjoys creating structure in a fast‑paced biotech environment and can confidently partner across Clinical Operations, Quality, Regulatory, IT, and external vendors to ensure inspection readiness and operational excellence. You’ll play a critical role in strengthening TMF strategy, oversight, quality, and reporting infrastructure while helping build scalable processes that support a growing clinical portfolio. This is a highly visible opportunity for someone who combines strategic thinking with hands‑on execution and enjoys driving continuous improvement. What You’ll Do: Lead TMF operational strategy and help build scalable, inspection‑ready processes across ongoing and future clinical studies Drive oversight of electronic TMF activities to ensure quality, completeness, accuracy, and regulatory compliance across internal teams and external partners Develop and refine TMF standards, governance models, workflows, and procedural documentation aligned with industry best practices and global regulations Act as a trusted TMF subject matter expert and strategic partner to Clinical Operations leadership and cross‑functional stakeholders Management of the eTMF system vendor Establish and monitor TMF health metrics, dashboards, and operational KPIs to identify trends, risks, and opportunities for improvement Conduct TMF reviews, quality assessments, and operational audits to ensure inspection readiness at all times For outsourced studies, partner closely with CROs and vendors to ensure deliverables, timelines, expectations, and performance standards are consistently met Support implementation, optimization, and integration of TMF‑related systems and technologies including eTMF platforms, CTMS, EDC, and other clinical systems Collaborate with IT and business stakeholders on system enhancements, upgrades, validation activities, and change management initiatives Help drive operational excellence by identifying process gaps, improving workflows, and creating sustainable solutions that support organizational growth Provide training and guidance to internal teams on TMF processes, expectations, and best practices Support clinical trial disclosure and registry compliance activities in partnership with cross‑functional teams What You Bring: Bachelor’s degree in a scientific, healthcare, or related discipline, or equivalent industry experience 10+ years of clinical research experience within biotech, pharmaceutical, or CRO environments Strong background in TMF operations, document management, and inspection readiness activities Hands‑on experience managing eTMF systems and TMF reporting processes Deep understanding of ICH‑GCP requirements, TMF best practices, and global regulatory expectationsExperience working collaboratively with CROs, vendors, and cross‑functional stakeholders in a matrixed environment Ability to operate effectively in a growing biotech company where priorities may evolve quickly Strong organizational skills with the ability to manage multiple priorities while maintaining exceptional attention to detail Excellent communication, collaboration, and problem‑solving skills A proactive mindset with the ability to work independently, influence others, and drive initiatives forward Work Environment: Hybrid role based in Needham, MA. Regular onsite collaboration expected approximately 2‑3 days per week depending on business needs. Occasional travel may be required to support audits, inspections, vendors, or cross‑functional meetings. You must be authorized to work in the US. We are unable to provide any sponsorship at this time. #J-18808-Ljbffr