Associate Director, Clinical Operations - TMF

Responsibilities: for the Associate Director, Clinical Operations - TMF include: • Lead TMF strategy, governance, and operational execution across multiple clinical trial programs, ensuring inspection readiness at all times. • Oversee TMF quality, completeness, accuracy, and timeliness in compliance with ICH-GCP, FDA regulations, and industry standards. • Develop and maintain TMF plans, filing structures, SOPs, work instructions, and controlled documentation. • Provide leadership and direct supervision to Clinical Operations Managers, TMF Specialists, and supporting clinical operations staff. • Serve as the primary TMF subject matter expert for sponsors, executive leadership, audits, inspections, and regulatory interactions. • Drive process improvement initiatives, risk mitigation strategies, CAPA activities, and TMF health metrics across the organization. • Support proposal development, resource forecasting, budget planning, and cross-functional clinical operations initiatives. Required Qualifications for the Associate Director, Clinical Operations - TMF include: • Bachelor's degree in Life Sciences, Clinical Research, or related health field; advanced degree preferred. • 10+ years of experience in pharmaceutical, biotechnology, CRO, or clinical research environments with increasing leadership responsibilities. • 6+ years of experience owning TMF strategy and managing TMF operations and teams. • Expert knowledge of ICH-GCP, FDA regulations, DIA TMF Reference Model, TMF best practices, and inspection readiness requirements. • Hands-on experience developing TMF plans, SOPs, work instructions, and governance documentation. • Proven experience supporting regulatory inspections, sponsor audits, and TMF remediation initiatives. • Expertise with Veeva Vault TMF required; experience with additional eTMF systems preferred. • Strong leadership, project management, communication, resource planning, and proposal development skills. • Experience in infectious disease, HIV, oncology, medical device, government-funded research, or Phase I clinical trials is a plus. Qualifications: for the Associate Director, Clinical Operations - TMF include: • Bachelor's degree in Life Sciences, Clinical Research, or related health field; advanced degree preferred. • 10+ years of experience in pharmaceutical, biotechnology, CRO, or clinical research environments with increasing leadership responsibilities. • 6+ years of experience owning TMF strategy and managing TMF operations and teams. • Expert knowledge of ICH-GCP, FDA regulations, DIA TMF Reference Model, TMF best practices, and inspection readiness requirements. • Hands-on experience developing TMF plans, SOPs, work instructions, and governance documentation. • Proven experience supporting regulatory inspections, sponsor audits, and TMF remediation initiatives. • Expertise with Veeva Vault TMF required; experience with additional eTMF systems preferred. • Strong leadership, project management, communication, resource planning, and proposal development skills. • Experience in infectious disease, HIV, oncology, medical device, government-funded research, or Phase I clinical trials is a plus. Compensation: : • Salary Range: $130,000-$155,000k • Full Benefits Package: Provided during interview process