Strategic Leader, Clinical Operations (Remote)

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

Benefits offered by this job

Remote work option

Healthcare benefits

401K

Sick Leave

Job summary

Piper Companies is seeking an Associate Director of Clinical Operations in Bethesda, MD (Remote) to oversee clinical operations across multiple programs and collaborate with clients and cross-functional teams.

The role requires a strong background in trial management, site monitoring, TMF oversight, and regulatory operations, with leadership in managing large, cross-functional teams and budgets. Oncology and infectious disease experience are a plus.

Qualifications

• Bachelor's degree in Life Sciences, Healthcare, or a related field; advanced degree preferred.
• 10+ years of experience in pharma, biotech, CRO, or clinical research.
• Hands-on experience in clinical operations, site monitoring, TMF management, or regulatory operations.
• At least 6 years of project management or clinical operations leadership experience.
• CRO experience with direct client-facing responsibilities.

Responsibilities

• Oversee 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, primarily oncology and infectious disease.
• 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.
• Oversee management of clinical trial management and monitoring teams, including direct reports.
• 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, budgets, and bid defense.
• Provide resource planning, forecasting, and oversight for departmental activities.

Skills

Leadership

Project management

Regulatory knowledge

Communication

Problem-solving

Clinical operations

Education

Bachelor's degree in Life Sciences or related field

Advanced degree preferred

Tools

TMF management

CTMS

Job description

Piper Companies is seeking an Associate Director of Clinical Operations in Bethesda, MD (Remote) to oversee clinical operations across multiple programs and collaborate with clients and cross-functional teams.

The role requires a strong background in trial management, site monitoring, TMF oversight, and regulatory operations, with leadership in managing large, cross-functional teams and budgets. Oncology and infectious disease experience are a plus.