Associate Director of Clinical Operations

About the role

Piper Companies is seeking an Associate Director of Clinical Operations to join a clinical research organization (CRO) located in Bethesda, MD (Remote).

Responsibilities

• Provide oversight of clinical operations activities including clinical trial management, site management, site monitoring, TMF oversight, and clinical systems activities.
• Lead clinical operations strategy and execution across government and commercial clinical programs, primarily supporting oncology, infectious disease, and other therapeutic areas.
• Manage project deliverables, timelines, budgets, resources, and operational activities across complex clinical development programs.
• Serve as a key client-facing leader, collaborating with internal teams and external stakeholders to support clinical trial execution and monitoring strategies.
• Oversee clinical trial management and monitoring teams, including direct management of Clinical Trial Managers and Clinical Project Managers.
• Monitor project performance, identify operational risks, implement mitigation strategies, and drive process improvements.
• Support quality management initiatives, CAPAs, KPI tracking, inspection readiness, audit preparation, and post-inspection activities.
• Contribute to SOP development, process improvement initiatives, proposal development, budget planning, and bid defense activities.
• Provide resource planning, forecasting, and oversight for departmental and project-specific clinical operations activities.

Requirements

• Bachelor's degree in Life Sciences, Healthcare, or a related field; advanced degree preferred.
• 10+ years of experience in the pharmaceutical, biotechnology, CRO, or clinical research industry.
• Hands-on experience in clinical operations, site monitoring, clinical trial management, TMF management, or regulatory operations.
• At least 6 years of project management or clinical operations leadership experience.
• Previous CRA, CTM, monitoring management, or site monitoring SME experience.
• CRO experience with direct client-facing responsibilities.
• Experience managing large-scale clinical programs and cross-functional teams.
• Strong knowledge of FDA regulations, GCP, ICH guidelines, clinical trial conduct, and clinical development processes.
• Strong leadership, resource management, presentation, communication, and problem-solving skills.
• Oncology experience preferred.

Pay

Rate Range: $145,000 - $170,000 annually

Benefits

• Comprehensive medical, dental, and vision coverage through Cigna
• 401K retirement plan
• Sick leave as required by law