Associate Director of Clinical Ops - TMF

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

What's the Job?

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.

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of: Manpower, Experis and Talent Solutions.

Experis® is a global leader in technology services and part of the ManpowerGroup® (NYSE: MAN) family of brands. We connect skilled technology professionals with meaningful opportunities where they can grow their careers, expand their expertise and make a real impact. Guided by the belief that it takes Human Ingenuity to unlock the true potential of technology, Experis helps people gain experience with leading organizations, build sought-after skills and take the next step toward a brighter future. Backed by ManpowerGroup's 75+ years of workforce expertise and global reach across more than 70 countries and territories, Experis brings the scale, insight and opportunity to help people and businesses thrive. ManpowerGroup is consistently recognized for its commitment to inclusion, ethics and responsible business, including being named one of the World's Most Ethical Companies. Learn more at Experis.com.

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.