Associate Director, TMF Clinical Operations

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

Job summary

Actalent is seeking a senior TMF Lead in Bethesda, MD, to helm TMF strategy, governance, and operations across multiple clinical programs. You will ensure complete, inspection-ready TMFs and lead cross-functional teams through study milestones.

The role requires 10+ years in pharma/clinical research with strong leadership, PM and stakeholder communication skills. Hybrid work arrangement and competitive compensation offered.

Qualifications

• Bachelor's degree in Life Sciences, Healthcare, or a related field.
• 10+ years of experience in pharmaceutical, biotechnology, CRO, or clinical research environments.
• 6+ years of experience leading TMF strategy, operations, and TMF teams.
• Strong expertise in TMF Operations, eTMF Systems, Inspection Readiness, ICH-GCP, Regulatory Compliance, Clinical Trial Documentation.
• Proven leadership experience managing teams and cross-functional initiatives.
• Excellent project management and stakeholder communication skills.
• Advanced degree (MS, PharmD, PhD, or MD) preferred.
• Experience supporting government and commercial clinical research programs preferred.
• Experience across multiple therapeutic areas including oncology, infectious disease, vaccines, medical devices, or pharmaceuticals preferred.

Responsibilities

• Lead TMF strategy, governance, and operational execution across multiple clinical programs.
• Ensure TMFs remain complete, accurate, compliant, and inspection-ready throughout the study lifecycle.
• Oversee TMF plans, structures, document requirements, filing standards, and study milestones.
• Manage TMF operations, quality reviews, document collection, and regulatory documentation processes.
• Serve as the primary TMF leader for executive stakeholders, sponsors, and cross-functional teams.
• Lead and mentor TMF Specialists, Clinical Operations Managers, and related staff.
• Drive process improvements, SOP development, quality initiatives, and CAPA activities.
• Monitor TMF health metrics, identify risks, and implement mitigation strategies.
• Support regulatory inspections, audits, and inspection readiness activities.
• Contribute to resource planning, budgeting, forecasting, proposals, and business development efforts.

Skills

TMF Operations

eTMF Systems

Inspection Readiness

ICH-GCP

Regulatory Compliance

Clinical Trial Documentation

Education

Bachelor's degree in Life Sciences/Healthcare

Advanced degree (MS/PhD/MD/PharmD) preferred

Job description

Location: Hybrid (2 days onsite, 3 days remote)

Required Qualifications

• Bachelor's degree in Life Sciences, Healthcare, or a related field.
• 10+ years of experience in pharmaceutical, biotechnology, CRO, or clinical research environments.
• 6+ years of experience leading TMF strategy, operations, and TMF teams.
• Strong expertise in:
  • TMF Operations
  • eTMF Systems
  • Inspection Readiness
  • ICH-GCP
  • Regulatory Compliance
  • Clinical Trial Documentation
• Proven leadership experience managing teams and cross-functional initiatives.
• Excellent project management and stakeholder communication skills.
• Advanced degree (MS, PharmD, PhD, or MD) (preferred).
• Experience supporting government and commercial clinical research programs (preferred).
• Experience across multiple therapeutic areas including oncology, infectious disease, vaccines, medical devices, or pharmaceuticals (preferred).

Key Responsibilities

• Lead TMF strategy, governance, and operational execution across multiple clinical programs.
• Ensure TMFs remain complete, accurate, compliant, and inspection-ready throughout the study lifecycle.
• Oversee TMF plans, structures, document requirements, filing standards, and study milestones.
• Manage TMF operations, quality reviews, document collection, and regulatory documentation processes.
• Serve as the primary TMF leader for executive stakeholders, sponsors, and cross-functional teams.
• Lead and mentor TMF Specialists, Clinical Operations Managers, and related staff.
• Drive process improvements, SOP development, quality initiatives, and CAPA activities.
• Monitor TMF health metrics, identify risks, and implement mitigation strategies.
• Support regulatory inspections, audits, and inspection readiness activities.
• Contribute to resource planning, budgeting, forecasting, proposals, and business development efforts.

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 Benefits Company Benefits Company Benefits

Job Type & Location

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

Application Deadline

This position is anticipated to close on Nov 4, 2026.

Workplace Type

This is a hybrid position in Bethesda,MD.

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.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.