Associate Director of Clinical Operations
Piper Companies · United States · 1 mo ago
RemoteRemoteAnalyst$145k–$170k/yrFull-time
About the role
Piper Companies is seeking an Associate Director of Clinical Operations to support a leading clinical research organization (CRO) focused on government and commercial clinical development programs. This position is Remote and supports teams based in Bethesda, MD.
Responsibilities
- Lead clinical operations strategy and execution across multiple clinical research programs.
- Oversee clinical trial management, site monitoring, TMF management, and clinical systems activities.
- Manage project timelines, budgets, resources, and key deliverables for complex studies.
- Serve as the primary client-facing operational leader for sponsors and stakeholders.
- Direct and mentor Clinical Trial Managers, Clinical Project Managers, and monitoring teams.
- Identify operational risks, implement mitigation strategies, and drive process improvements.
- Support inspection readiness, CAPAs, KPI tracking, audit activities, SOP development, and proposal initiatives.
Required Qualifications
- Bachelor’s degree in Life Sciences, Healthcare, or a related field; advanced degree preferred.
- 10+ years of experience within pharmaceutical, biotechnology, CRO, or clinical research environments.
- Hands-on experience in clinical operations, clinical trial management, site monitoring, or regulatory operations.
- 6+ years of clinical operations leadership or project management experience.
- Previous experience as a CRA, CTM, Monitoring Manager, or Site Monitoring SME.
- CRO experience with direct client-facing responsibilities and sponsor interaction.
- Strong knowledge of FDA regulations, GCP, ICH guidelines, and clinical development processes.
- Experience leading large-scale clinical programs and cross-functional teams.
- Oncology experience preferred.
Compensation
- Salary Range: $145,000 - $170,000 annually
- Full Benefits Package: Medical, Dental, Vision, 401K, Paid Time Off, Paid Holidays, and additional company-sponsored benefits.