Senior TMF Strategy Director - Clinical Ops

Technical Resources International, Inc.; Bethesda (MD); Hybrid; USD 130,000 - 155,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Technical Resources International, Inc. seeks an Associate Director, Clinical Operations-TMF to lead TMF strategy, quality, and inspection readiness across multiple programs in Bethesda, MD.

You will oversee TMF governance, staff, and cross-functional collaboration with sponsor and executive teams, ensuring timely, accurate documentation in compliance with FDA and ICH guidelines. Hybrid role with two days in the Bethesda office and three remote, requiring a Master’s degree and 10+ years in

Qualifications

• 10 years minimum experience in pharma/biotech with leadership responsibilities.
• At least 6 years owning TMF strategy and TMF operations.
• Bachelor’s Degree in life science or related field; advanced degree a plus.
• Hybrid work: 2 days in Bethesda office, 3 days remote.

Responsibilities

• Owns TMF strategy, quality, inspection-readiness, systems, processes, staff leadership, and client oversight.
• Provide strategic and operational leadership for TMF governance and quality standards.
• Establish and improve TMF governance, procedures, and filing conventions.
• Oversee TMF health across all clinical trials and ensure sponsor alignment.
• Lead TMF team including TMF Specialists and Clinical Operations staff.
• Develop TMF plans for new studies, including structure and milestones.
• Coordinate TMF activities with regulatory and GCP requirements and TMF systems.
• Communicate effectively in a matrix organization with cross-functional teams.

Skills

TMF governance

Leadership

Strategic planning

Regulatory knowledge

Education

Master's Degree

Bachelor’s Degree in life science or health field

Tools

TMF systems/tools

Job description

Technical Resources International, Inc. seeks an Associate Director, Clinical Operations-TMF to lead TMF strategy, quality, and inspection readiness across multiple programs in Bethesda, MD.

You will oversee TMF governance, staff, and cross-functional collaboration with sponsor and executive teams, ensuring timely, accurate documentation in compliance with FDA and ICH guidelines. Hybrid role with two days in the Bethesda office and three remote, requiring a Master’s degree and 10+ years in