Associate Director of Clinical Ops - TMF

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

Position Overview

We are seeking an experienced Associate Director, Clinical Operations (TMF) to provide strategic and operational leadership for Trial Master File (TMF) management across a portfolio of clinical programs at a global contract research organization (CRO). This individual will be responsible for TMF strategy, inspection readiness, quality oversight, process improvement, team leadership, and sponsor engagement while ensuring compliance with applicable regulatory requirements and industry standards.

The ideal candidate is a strategic clinical operations leader with deep TMF expertise, strong regulatory knowledge, and a proven track record leading high‑performing teams across diverse therapeutic areas and complex clinical development programs.

Job Title: Associate Director of Clinical Operations - TMF

Location: Bethesda, MD (Hybrid: 2 Days Onsite, 3 Days Remote)

Pay Range: $130,000 - $155,000

TMF Leadership & Oversight

• Own and drive the organization's TMF strategy, governance, and inspection readiness initiatives.
• Ensure the completeness, accuracy, quality, and timeliness of TMF documentation across all clinical studies.
• Develop TMF plans, indices, filing structures, document requirements, and study‑specific documentation strategies.
• Serve as the senior TMF subject matter expert for leadership teams and external stakeholders.
• Lead initiatives to scale TMF operations across a growing clinical trial portfolio.

Clinical Operations Management

• Provide oversight of TMF project management activities, documentation collection, review, and filing processes.
• Support complex clinical programs across multiple therapeutic areas, including infectious disease, oncology, medical devices, and drug development.
• Manage study deliverables, timelines, budgets, risks, and operational performance metrics.
• Collaborate effectively in a matrixed environment with cross‑functional teams and leadership.

Quality & Compliance

• Ensure adherence to FDA regulations, ICH‑GCP guidelines, sponsor requirements, and internal quality standards.
• Drive process improvements, SOP development, CAPA activities, and quality management initiatives.
• Monitor key performance indicators and identify opportunities to improve efficiency and compliance.
• Support audit and inspection readiness activities, including preparation, execution, and follow‑up actions.

Team Leadership

• Directly manage Clinical Operations Managers, TMF Specialists, and supporting clinical operations staff.
• Lead hiring, mentoring, performance management, and professional development efforts.
• Oversee resource allocation, staffing forecasts, and workload planning across multiple projects.
• Foster a culture of quality, accountability, and continuous improvement

Business Support

• Participate in proposal development, budget planning, bid defense activities, and business development initiatives.
• Support revenue forecasting and resource planning efforts.
• Contribute to corporate process improvement and strategic growth initiatives.

What's Needed?

• Bachelor's degree in Life Sciences, Healthcare, or a related field.
• Minimum of 10 years of experience in pharmaceutical, biotechnology, CRO, or clinical research environments; direct CRO experience is highly preferred.
• At least 6 years of experience leading TMF strategy, operations, and teams.
• Strong working knowledge of Trial Master File (TMF) management, FDA regulations, ICH‑GCP guidelines, clinical trial documentation requirements, and inspection readiness best practices.
• Excellent communication, organizational, and stakeholder management skills.
• Demonstrated experience leading teams and managing complex clinical programs.

Preferred Qualifications

• Master's degree, PhD, PharmD, MD, or other advanced degree in a life science or healthcare-related discipline.
• Experience supporting both government-sponsored and commercial clinical research programs.
• Expertise with electronic TMF systems and clinical technology platforms.
• Proven success implementing process improvements and scaling clinical operations functions.

What's in it for me?

• Opportunity to lead impactful clinical operations initiatives in a reputable organization.
• Collaborate with a diverse and innovative team dedicated to advancing healthcare solutions.
• Engage in professional development and growth within a supportive environment.
• Work in a hybrid setting that promotes work‑life balance and flexibility.
• Competitive salary package aligned with your expertise and experience.