Associate Director of Clinical Operations - 172436

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 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.

Compensation for Associate Director of Clinical Operations includes:

• 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.

Keywords: Associate Director Clinical Operations, Clinical Operations, Clinical Trial Management, Clinical Project Management, Clinical Study Management, Clinical Monitoring, Site Monitoring, CRA, Clinical Research Associate, CTM, Clinical Trial Manager, Clinical Project Manager, CRO, Contract Research Organization, Oncology, Clinical Development, Drug Development, Clinical Research, FDA, GCP, ICH, Regulatory Compliance, TMF, Trial Master File, CTMS, Inspection Readiness, Audit Preparation, CAPA, Risk Management, Resource Management, Program Management, Portfolio Management, Government Contracts, Sponsor Oversight, Clinical Operations Strategy, Monitoring Management, Clinical Systems, Clinical Site Management, Clinical Study Start-Up, Cross-Functional Leadership, Quality Management System, Proposal Development, Bid Defense, Budget Management, Clinical Program Oversight, Oncology Trials, Infectious Disease Trials, Phase I Clinical Trials, Biotechnology, Pharmaceutical Industry.

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