Remote Associate Director, Clinical Operations Lead

Piper Companies; United States; Remote; USD 145,000 - 170,000; Full time

Job summary

Piper Companies is seeking an Associate Director of Clinical Operations to support a leading CRO focused on government and commercial programs. This remote role supports teams based in Bethesda, MD.

Responsibilities include leading ops strategy, overseeing trials, and mentoring PMs and monitors. Requires 10+ years in clinical operations and strong FDA/GCP/ICH knowledge, with oncology experience preferred.

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.

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.

Skills

Clinical Operations

Clinical Trial Management

Site Monitoring

Regulatory Operations

Project Management

FDA regulations

GCP

ICH guidelines

Sponsor interaction

Leadership

Oncology experience

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Job description

Piper Companies is seeking an Associate Director of Clinical Operations to support a leading CRO focused on government and commercial programs. This remote role supports teams based in Bethesda, MD.

Responsibilities include leading ops strategy, overseeing trials, and mentoring PMs and monitors. Requires 10+ years in clinical operations and strong FDA/GCP/ICH knowledge, with oncology experience preferred.