Associate Director, TMF Clinical Operations

Job Description

Job Description

Job Title: Associate Director, TMF Clinical Operations

Job Description

The Associate Director, TMF Clinical Operations provides strategic and operational leadership for the Trial Master File (TMF) function, ensuring inspection-ready documentation across multiple large-scale clinical programs and therapeutic areas. This role owns TMF strategy, governance, quality, systems, processes, and staff leadership, while serving as the senior TMF point of contact for internal leadership and external sponsors. The position combines hands-on TMF oversight with line management responsibilities, cross-functional collaboration, and continuous process improvement within a growing clinical trial portfolio.

Responsibilities

• Own and lead the overall TMF strategy, including governance, quality, inspection readiness, systems, processes, and client/study oversight.
• Provide strategic and operational leadership for the TMF function to ensure consistent, inspection-ready trial documentation across several large-scale clinical programs and diverse therapeutic areas.
• Establish, maintain, and continuously improve TMF governance, processes, procedures, work instructions, and quality standards in alignment with applicable regulations, ICH GCP, sponsor requirements, and internal policies.
• Oversee the completeness, accuracy, quality, timeliness, and overall health of the TMF across all clinical trials within the organizations portfolio.
• Serve as the senior TMF point of contact for executive leadership and key sponsor stakeholders, providing clear updates, guidance, and strategic input.
• Provide department leadership as the direct supervisor to Clinical Operations Managers, TMF Specialists, and other clinical operations personnel supporting TMF or related activities.
• Develop and implement TMF plans, indices, and strategies for new studies, including defining TMF structure, document requirements, filing conventions, and key milestones.
• Oversee Clinical Operations TMF activities, including TMF project management, documentation, and review/collection, ensuring compliance with FDA requirements, GCP/ICH guidelines, and technical requirements within one or more TMF systems or tools.
• Support one or more government or commercial contracts in multiple therapeutic areas, such as infectious disease (including vaccines and therapeutics), oncology, medical devices, or drug abuse.
• Lead TMF project management oversight within one or more complex drug development programs, managing deliverables within budget and against well-defined timelines.
• Communicate effectively within a matrix management organization and represent the clinical team in cross-functional collaborations.
• Lead strategic initiatives to scale TMF operations across a growing clinical trial portfolio, aligning resources and processes with organizational growth.
• Collaborate with division and cross-functional Clinical Operations leadership on clinical strategy and vision to support ongoing and planned clinical trial activities.
• Inform division leadership on the overall status of program and project TMFs, highlighting potential issues and proposing mitigation strategies.
• Ensure documentation of processes and workflows is followed and completed within projected timelines, determining and implementing corrective actions to prevent and remediate delays.
• Identify process gaps and propose solutions to improve efficiency and quality of TMF deliverables, maintaining a high level of accuracy and attention to detail in a fast-paced environment with shifting priorities.
• Support and comply with the companys Quality Management System policies and procedures, including driving innovative performance improvement solutions.
• Lead and support corrective and preventive action (CAPA) initiatives, perform risk-based quality content reviews, and monitor internal and external KPIs as required by clients.
• Contribute to corporate initiatives such as process streamlining, SOP development, business development proposals, and revenue and resource forecasting.
• Manage line responsibilities including staff hiring, onboarding, performance management, and professional development for TMF-related personnel.
• Oversee resource management, tracking, and level-of-effort projections for one or more groups within the clinical operations department and/or project functional areas.
• Participate in proposal writing for government and commercial clients, including budget development and bid defense meetings, as needed.
• Support inspection readiness activities across the organization and assist with department audit preparation, post-inspection implementation, and follow-up actions.
• Partner closely with senior Clinical Operations leadership, including the Vice President of Clinical Operations, to align TMF operations with broader organizational goals and growth plans.

Essential Skills

• Minimum of 10 years of experience in the pharmaceutical or biotechnology industry, including Contract Research Organization (CRO) or other global clinical trials or research environments, with progressive leadership responsibility.
• At least 6 years of experience owning TMF strategy and managing or directing TMF operations and teams.
• Bachelors degree in a life science or other health-related field.
• Deep expertise in TMF strategy, TMF operations, and inspection readiness for global clinical trials.
• Hands-on experience with electronic Trial Master File (eTMF) systems and tools.
• Strong knowledge of Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines.
• Demonstrated ability to ensure TMF completeness, accuracy, quality, and timeliness across multiple clinical programs.
• Proven experience leading and supervising Clinical Operations Managers, TMF Specialists, and other clinical operations staff.
• Experience managing TMF activities and deliverables within budget and to defined timelines in complex drug development programs.
• Ability to operate effectively in a matrix management organization and represent clinical operations in cross-functional settings.
• Strong communication skills for engaging executive leadership, sponsors, and cross-functional stakeholders.
• Demonstrated ability to maintain high accuracy and attention to detail in a fast-paced environment with shifting priorities.
• Experience with quality management systems, including risk-based quality reviews and KPI monitoring.

Additional Skills & Qualifications

• Advanced degree such as PhD, PharmD, MD, or Masters degree in a life science or health-related field is a plus.
• Experience supporting government and commercial contracts in multiple therapeutic areas, including infectious disease (vaccines and therapeutics), oncology, medical devices, or drug abuse.
• Background in contributing to or leading corporate initiatives, such as SOP development, process improvement, and business development proposals.
• Experience with corrective and preventive actions (CAPA) and continuous improvement methodologies.
• Exposure to revenue and resource forecasting in a clinical operations environment.
• Experience participating in budget development and bid defense meetings for clinical programs.
• Demonstrated ability to build and lead high-performing teams, including hiring, coaching, and developing staff.
• Interest in working closely with senior Clinical Operations leadership and growing within an organization that prioritizes internal promotion.
• Motivation to work cross-functionally and collaborate with multiple internal and external stakeholders.

Work Environment

This position operates in a hybrid work environment, combining both on-site and remote work. Team members typically work two days on site and three days remotely each week, enabling close collaboration with clinical operations leadership and cross-functional partners while maintaining flexibility. The role involves frequent interaction with electronic Trial Master File (eTMF) systems, quality management tools, and other clinical operations platforms. The environment is fast-paced and dynamic, with shifting priorities driven by multiple large-scale clinical programs and diverse therapeutic areas. The organization emphasizes internal growth, cross-functional exposure, and direct collaboration with senior Clinical Operations leadership, offering opportunities to influence strategy, lead initiatives, and develop professionally.

Job Type & Location

This is a Permanent position based out of Bethesda, MD.

Pay and Benefits

The pay range for this position is $130000.00 - $155000.00/yr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Company BenefitsCompany BenefitsCompany Benefits

Workplace Type

This is a hybrid position in Bethesda,MD.

Application Deadline

This position is anticipated to close on Oct 13, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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