Associate Director, TMF Operations

We are an emerging biotech company focused on developing transformative oncology therapies. As we advance our clinical pipeline, we are seeking an Associate Director, TMF Operations to lead Trial Master File (TMF) operations across our oncology programs. This role provides strategic leadership and oversight of electronic Trial Master File (TMF) operations, enhancing functionality, efficiency, scalability, and quality. The ideal candidate will possess TMF system and process expertise, exceptional vendor oversight, and a strong foundation in inspection readiness and support. 

Beyond TMF responsibilities, this position oversees Clinical Operations reporting, metrics, KPIs, and analytics. The role involves collaborating with senior leaders and key stakeholders to establish, manage, and generate reports and analytics that support performance measurement, delivery optimization, and continuous improvement. 

This position currently requires a minimum of three days onsite per week in Princeton, NJ. The company reserves the right to modify onsite requirements, including transitioning to full-time onsite, based on business needs.

• Provide leadership and strategic direction to ensure TMF processes and related documentation are of the highest quality for in-house and outsourced studies. 

• Develop and oversee global TMF-related standards, standard operating procedures (SOPs) and TMF Plans that are in line with relevant regulations and industry best practices. 

• Ensure TMF structure aligns with the DIA TMF Reference Model and supports complex oncology protocols (e.g., adaptive designs, biomarker-driven studies). 

• Provide expertise and leadership to ensure TMF inspection readiness and facilitate seamless support of audits and regulatory inspections.  

• Develop, generate, analyse, and report on standard TMF metrics/KPIs to demonstrate TMF health. 

• Facilitate and perform periodic TMF health checks and QC reviews to ensure completeness, accuracy, and timeliness.  

• Provide operational leadership to TMF vendor budget negotiations and management of TMF operations spend.  

• Create and lead training across all relevant business units/functional areas on business processes around clinical document management and eTMF system(s).  

• Oversee CRO/vendor partners to ensure TMF tasks are completed according to contractual requirements.  

• Serve as area representative for the implementation of any systems or processes that would interface/integrate with TMF (e.g., CTMS, EDMS, ISF, CDMS/EDC).  

• Partner with IT and internal clinical business operations resources to support the strategic lifecycle of TMF including, but not limited to, version releases, system updates, validation or user acceptance testing, and integrations with other clinical applications through change management 

• Oversee and support the registration, maintenance, and compliance of clinical trial postings on appropriate clinical trial registries (e.g., ClinicalTrials.gov) in coordination with the cross-functional team. 

• Support the development and coordination of procedures and programs to enhance team understanding and compliance with clinical trial disclosure regulations and requirements. 

• Bachelor’s degree or a combination of relevant education and applicable experience may be considered.  

• 10+ years of experience in clinical research within the pharmaceutical/biotech industry and a minimum of 5 years in TMF process management and oversight. 

• Demonstrated proficiency with eTMF systems and TMF metrics/reporting, 

• Experience with Veeva eTMF platform, strongly preferred. 

• Strong understanding of ICH-GCP, DIA TMF Reference Model, and global regulatory requirements. 

• Comfortable working in a fast-paced, evolving environment with limited structure. 

• Clear and timely communication skills. 

• Strong organizational/prioritization skills for the management of workload and attention to detail.