Senior TMF & Clinical Operations Director (Hybrid)

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

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.