Senior TMF Clinical Operations Leader (Hybrid)

Actalent; United States; Hybrid; USD 130,000 - 155,000; Full time

Job summary

Actalent is seeking an Associate Director of TMF Clinical Operations to lead TMF strategy across multiple programs. The role is based in Bethesda, MD with a hybrid onsite/remote schedule. The candidate will ensure inspection-ready TMFs and oversee cross-functional TMF teams.

Ideal candidates will have 10+ years in life sciences, strong TMF/eTMF expertise, and a track record of leadership and project management. Advanced degrees are preferred but not mandatory.

Qualifications

• Bachelor's degree in Life Sciences, Healthcare, or a related field.
• 10+ years in pharmaceutical/biotech/CRO/clinical research environments.
• 6+ years leading TMF strategy, operations, and TMF teams.

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

Leadership

Project Management

Stakeholder Communication

Education

Bachelor's degree in Life Sciences/Healthcare/related field

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

Job description

Actalent is seeking an Associate Director of TMF Clinical Operations to lead TMF strategy across multiple programs. The role is based in Bethesda, MD with a hybrid onsite/remote schedule. The candidate will ensure inspection-ready TMFs and oversee cross-functional TMF teams.

Ideal candidates will have 10+ years in life sciences, strong TMF/eTMF expertise, and a track record of leadership and project management. Advanced degrees are preferred but not mandatory.