Associate Director of Clinical Operations

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

Responsibilities of the Associate Director of Clinical Operations include:

• 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.

Qualifications for the Associate Director of Clinical Operations include:

• 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.

• Rate Range: $145,000 - $170,000 annually
• Comprehensive Benefit Package:
  Cigna Medical/Dental/Vision, 401K, Sick Leave as Required by Law

This job is open for applications on August 19th, 2026. Applications will be accepted at least 30 days from the posting date.

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