TMF Strategy & Ops Associate Director

ManpowerGroup Global, Inc.; Bethesda (MD); Hybrid; USD 130,000 - 155,000; Full time

Job summary

ManpowerGroup Global, Inc. in Bethesda, MD is seeking an experienced Associate Director of Clinical Operations - TMF to lead TMF strategy, inspection readiness, and quality oversight across a global portfolio.

You will direct a team of TMF professionals and collaborate with sponsors to ensure compliant, timely documentation. The role requires 10+ years in pharma/CRO, strong regulatory knowledge, and proven leadership in TMF operations; hybrid work schedule and competitive compensation are

Qualifications

• 10+ years in pharma/biotech/CRO or clinical research
• 6+ years leading TMF strategy and teams
• Strong TMF knowledge and inspection readiness expertise
• Excellent communication and stakeholder management skills
• Experience with TMF governance, SOPs, and CAPA processes
• Experience supporting government-sponsored and commercial programs

Responsibilities

• Lead TMF strategy, governance, and inspection readiness across a global program portfolio
• Oversee TMF project management, documentation collection, review, and filing
• Support cross-functional teams and sponsor engagement in TMF matters
• Ensure compliance with FDA, ICH-GCP, and internal standards
• Lead hiring, mentoring, and performance management for TMF staff
• Contribute to budgeting, forecasting, and strategic growth initiatives

Skills

TMF strategy

Regulatory knowledge

Team leadership

Stakeholder management

Process improvement

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Master's degree or higher

Tools

Electronic TMF systems

Job description

ManpowerGroup Global, Inc. in Bethesda, MD is seeking an experienced Associate Director of Clinical Operations - TMF to lead TMF strategy, inspection readiness, and quality oversight across a global portfolio.

You will direct a team of TMF professionals and collaborate with sponsors to ensure compliant, timely documentation. The role requires 10+ years in pharma/CRO, strong regulatory knowledge, and proven leadership in TMF operations; hybrid work schedule and competitive compensation are