[Hiring] Associate Director, Clinical Operations @Piper Companies

Role Description

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.

• 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.

Qualifications

• 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.

Requirements

• 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