Associate Director Of TMF Operations

Job Title: Associate Director of TMF Operations

Job Description

The Associate Director of TMF Operations serves as the internal subject matter expert and governance leader for a sponsor‑owned Trial Master File (TMF) environment. This role ensures continuous inspection readiness, robust TMF quality and compliance, and effective oversight of TMF vendors and functional service provider (FSP) support as the clinical pipeline grows and scales. The position offers true end‑to‑end accountability for TMF health, inspection readiness, and vendor governance within an eTMF setting and provides the opportunity to operate as the central TMF authority in a growing biotechnology organization.

Responsibilities

• Provide end‑to‑end governance and oversight of TMF health across all active studies within a sponsor‑owned eTMF environment.
• Oversee and manage external TMF vendors and FSP support teams to ensure high‑quality, compliant TMF delivery.
• Ensure the Trial Master File consistently meets ICH‑GCP and global regulatory expectations, maintaining continuous readiness for FDA, EMA, and MHRA inspections.
• Develop, own, and maintain TMF key performance indicators, including completeness, timeliness, and quality metrics across all studies.
• Analyze TMF metrics and trends and communicate clear, data‑driven reports and insights to Clinical Operations, Quality Assurance, Compliance, Regulatory, and senior leadership.
• Lead TMF inspection readiness activities, including preparation, documentation review, and response strategies for regulatory inspections.
• Drive TMF process improvements and standardization as legacy paper and historical studies are migrated into the eTMF system.
• Lead change management initiatives related to TMF processes, systems, and governance to support scalability and operational excellence.
• Act as the central TMF escalation point and trusted advisor to Clinical Operations, QA, Compliance, and Regulatory teams.
• Provide strategic TMF leadership to align TMF operations with clinical development, regulatory submission, and inspection strategies.
• Oversee the management and quality of clinical and regulatory documentation within the TMF to support clinical trials and regulatory submissions.
• Establish and maintain governance frameworks for TMF vendor and FSP performance, including expectations, oversight mechanisms, and issue resolution.
• Collaborate cross‑functionally to ensure TMF processes are integrated with broader clinical, quality, and regulatory workflows.
• Support data review and quality checks of TMF content to ensure accuracy, completeness, and compliance with internal standards and external regulations.
  
  

Essential Skills

• 10 years of clinical research experience, with sponsor‑side experience preferred and CRO experience considered.
• Proven expertise in TMF management within a sponsor‑owned environment.
• Strong knowledge of ICH‑GCP and global regulatory requirements related to TMF, clinical trials, and inspections.
• Demonstrated experience in inspection readiness and regulatory compliance for agencies such as FDA, EMA, and MHRA.
• Hands‑on experience with eTMF systems, with Veeva eTMF experience strongly preferred.
• Proven ability to provide vendor and FSP governance, including oversight of external TMF service providers.
• Experience developing, managing, and reporting TMF metrics and health indicators such as completeness, timeliness, and quality.
• Strong background in clinical documentation and regulatory documents within the context of clinical trials and regulatory submissions.
• Demonstrated strategic TMF leadership, including governance and process ownership.
• Solid understanding of Good Clinical Practice (GCP) and its application to TMF operations.
• Ability to lead TMF inspection activities, including preparation, response, and follow‑up.
• Bachelor’s degree in life sciences or a related field.
  
  

Additional Skills & Qualifications

• Advanced degree in life sciences or a related discipline is preferred.
• Experience working in a growing biotechnology or similarly dynamic clinical development environment.
• Experience with change management and process optimization in TMF or clinical operations.
• Proven ability to act as a trusted advisor and central escalation point to Clinical Operations, QA, Compliance, and Regulatory teams.
• Strong analytical skills to interpret TMF data and metrics and translate findings into actionable improvements.
• Excellent communication skills for presenting TMF health and KPIs to cross‑functional stakeholders and senior leadership.
• Demonstrated ability to work in a collaborative, quality‑driven culture where TMF is treated as a critical business function.
  
  

Work Environment

The role is primarily on‑site, with an expectation of working 4 to 5 days per week in a corporate office environment located in either Radnor, PA or Gaithersburg, MD. The position operates within a sponsor‑owned eTMF environment, leveraging technologies such as Veeva for electronic document and TMF management. The culture emphasizes collaboration, quality, and viewing TMF as a core business function integral to clinical development and regulatory success. The work involves close interaction with Clinical Operations, Quality Assurance, Compliance, Regulatory, and external TMF vendors and FSP partners in a professional office setting.

Job Type & Location

This is a Permanent position based out of Radnor, PA.

Pay And Benefits

The pay range for this position is $175000.00 - $180000.00/yr.

• PTO – 20 Vacations days per years - Holidays – 9 standard holidays and 2 floating holidays - Sick Time - 10 Days
  
  

Workplace Type

This is a hybrid position in Radnor,PA.

Application Deadline

This position is anticipated to close on Apr 21, 2026.

Diversity, Equity & Inclusion

At Actalent, Diversity And Inclusion Are a Bridge Towards The Equity And Success Of Our People. DE&I Is Embedded Into Our Culture Through

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people
  
  

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.