Remote Associate Director, Clinical Operations

Zachary Piper Solutions; Bethesda (MD); Remote; USD 145,000 - 170,000; Full time

Benefits offered by this job

Health benefits

401K

Sick leave as required by law

Job summary

Piper Companies is seeking an Associate Director of Clinical Operations to lead end-to-end clinical trial management for a CRO, based in Bethesda, MD with remote work options.

The role requires 10+ years in pharma/CRO, strong leadership, regulatory knowledge (FDA/GCP/ICH), and proven ability to manage large cross-functional programs across oncology and infectious diseases. Competitive compensation and comprehensive benefits.

Qualifications

• Bachelor's degree in Life Sciences, Healthcare, or related field; advanced degree preferred.
• 10+ years in pharma/biotech/CRO/clinical research industry.
• Hands-on experience in clinical operations, site monitoring, TMF, or regulatory operations.

Responsibilities

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

Skills

Clinical operations leadership

Project management

Cross-functional leadership

FDA regulations knowledge

GCP/ICH expertise

Site monitoring

TMF oversight

Budgeting

Client-facing

Oncology experience preferred

Education

Bachelor's degree in Life Sciences, Healthcare, or related field

Advanced degree preferred

Tools

CTMS

Job description

Piper Companies is seeking an Associate Director of Clinical Operations to lead end-to-end clinical trial management for a CRO, based in Bethesda, MD with remote work options.

The role requires 10+ years in pharma/CRO, strong leadership, regulatory knowledge (FDA/GCP/ICH), and proven ability to manage large cross-functional programs across oncology and infectious diseases. Competitive compensation and comprehensive benefits.