Clinical Operations Strategy Lead

Technical Resources International, Inc.; North Bethesda (MD); On-site; USD 130,000 - 175,000; Full time

Job summary

Technical Resources International, Inc. seeks an Associate Director, Clinical Operations to oversee clinical operations activities, including project management, site management, and TMF/document review, with strong regulatory, data management, and scientific writing know‑how.

The role requires 10+ years in pharma/biotech, leadership in a matrix organization, and experience with government or commercial contracts.

Qualifications

• Broad multidisciplinary understanding of pharmaceutical clinical development and regulatory requirements.
• Ability to mentor staff and drive risk-based mitigation and CAPA actions.
• Strong facilitation, presentation, and problem-solving skills in a matrix environment.
• Experience with clinical systems (CTMS, TMF) and data management processes.

Responsibilities

• Oversee clinical operations activities including project/site management and TMF/document review.
• Support government or commercial contracts across therapeutic areas.
• Manage multiple programs within budget and timelines.
• Lead cross-functional collaboration and communicate with division leadership.
• Contribute to operational strategy and process improvement.

Skills

Regulatory knowledge

Project management

Leadership

Communication

Quality management

Education

Bachelor's Degree

Tools

Microsoft Word

PowerPoint

Excel

Microsoft Project

Job description

Technical Resources International, Inc. seeks an Associate Director, Clinical Operations to oversee clinical operations activities, including project management, site management, and TMF/document review, with strong regulatory, data management, and scientific writing know‑how.

The role requires 10+ years in pharma/biotech, leadership in a matrix organization, and experience with government or commercial contracts.