Associate Director of Clinical Ops - TMF

Experis; Bethesda (MD); Hybrid; USD 130,000 - 155,000; Full time

Benefits offered by this job

Hybrid work model

Competitive salary

Professional development opportunities

Work-life balance

Job summary

Experis is seeking an Associate Director of Clinical Ops (TMF) in Bethesda, MD. The role leads TMF strategy, governance, inspection readiness, and quality oversight across a global portfolio, with 2 days onsite and 3 days remote.

The candidate will manage TMF operations, ensure regulatory compliance (FDA/ICH-GCP), and drive improvements across multiple therapeutic areas, while mentoring a growing team in a hybrid work setting.

Qualifications

• Bachelor's degree in Life Sciences, Healthcare, or related field.
• Minimum of 10 years of experience in pharma/biotech/CRO or clinical research; CRO exposure preferred.
• At least 6 years leading TMF strategy, operations, and teams.
• Strong knowledge of TMF management, FDA regulations, ICH-GCP, and inspection readiness.
• Excellent communication, organizational, and stakeholder management skills.
• Demonstrated experience leading teams on complex clinical programs.

Responsibilities

• Own and drive TMF strategy, governance, and inspection readiness initiatives.
• Ensure completeness, quality, and timeliness of TMF documentation across studies.
• Develop TMF plans, indices, filing structures, and study documentation strategies.
• Senior TMF SME to leadership and external stakeholders.
• Scale TMF operations across a growing trial portfolio.
• Provide oversight of TMF project management, documentation collection, and filing.
• Support complex programs across multiple therapeutic areas.
• Manage deliverables, timelines, budgets, risks, and performance metrics.
• Collaborate in a matrixed environment with cross-functional teams.
• Ensure FDA/ICH-GCP compliance; drive SOPs and CAPA; monitor KPIs.
• Support audit and inspection readiness activities.
• Directly manage TMF staff; hire, mentor, and develop talent.
• Participate in proposals, budgeting, and strategic growth initiatives.

Skills

TMF management

Regulatory knowledge

Team leadership

Stakeholder management

Clinical operations

FDA/ICH-GCP familiarity

Communication

Strategic planning

Education

Bachelor's degree in Life Sciences / Healthcare

Master's degree / PhD / PharmD / MD (preferred)

Tools

Electronic TMF systems

Job description

Associate Director of Clinical Ops - TMF

Bethesda, MD 20817

Applying to

Experis

Associate Director of Clinical Ops - TMF

Experis

Bethesda, MD 20817

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 leadinghigh-performing teams acrossdiverse 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.

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 leadinghigh-performing teams acrossdiverse therapeutic areas and complex clinical development programs.

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.

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.

Associate Director of Clinical Ops - TMF