Associate Director, Clinical Operations - TMF

Associate Director, Clinical Operations - TMF

Job Summary: 

Piper Companies is seeking an Associate Director, Clinical Operations - TMF to support a leading clinical research organization managing government and commercial clinical trial programs across multiple therapeutic areas. This position is Remote in the DMV. 

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. 

Compensation: 

• Salary Range: $130,000-$155,000k

• Full Benefits Package: Provided during interview process

Keywords: 

Associate Director Clinical Operations, Trial Master File, TMF, eTMF, Veeva Vault TMF, Clinical Operations, CRO, Clinical Research, FDA Regulations, ICH-GCP, DIA TMF Reference Model, Inspection Readiness, Sponsor Audits, Regulatory Compliance, TMF Governance, Quality Management, CAPA, SOP Development, Document Management, Clinical Trial Management, Oncology Clinical Trials, Infectious Disease Clinical Trials, HIV Research, Government Contracts, Clinical Project Management.