Senior TMF Strategy Lead, Clinical Operations

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

Benefits offered by this job

Hybrid work model

Competitive salary

Professional development opportunities

Work-life balance

Job summary

Experis is seeking an Associate Director of Clinical Ops (TMF) in Bethesda, MD. The role leads TMF strategy, governance, inspection readiness, and quality oversight across a global portfolio, with 2 days onsite and 3 days remote.

The candidate will manage TMF operations, ensure regulatory compliance (FDA/ICH-GCP), and drive improvements across multiple therapeutic areas, while mentoring a growing team in a hybrid work setting.

Qualifications

• Bachelor's degree in Life Sciences, Healthcare, or related field.
• Minimum of 10 years of experience in pharma/biotech/CRO or clinical research; CRO exposure preferred.
• At least 6 years leading TMF strategy, operations, and teams.
• Strong knowledge of TMF management, FDA regulations, ICH-GCP, and inspection readiness.
• Excellent communication, organizational, and stakeholder management skills.
• Demonstrated experience leading teams on complex clinical programs.

Responsibilities

• Own and drive TMF strategy, governance, and inspection readiness initiatives.
• Ensure completeness, quality, and timeliness of TMF documentation across studies.
• Develop TMF plans, indices, filing structures, and study documentation strategies.
• Senior TMF SME to leadership and external stakeholders.
• Scale TMF operations across a growing trial portfolio.
• Provide oversight of TMF project management, documentation collection, and filing.
• Support complex programs across multiple therapeutic areas.
• Manage deliverables, timelines, budgets, risks, and performance metrics.
• Collaborate in a matrixed environment with cross-functional teams.
• Ensure FDA/ICH-GCP compliance; drive SOPs and CAPA; monitor KPIs.
• Support audit and inspection readiness activities.
• Directly manage TMF staff; hire, mentor, and develop talent.
• Participate in proposals, budgeting, and strategic growth initiatives.

Skills

TMF management

Regulatory knowledge

Team leadership

Stakeholder management

Clinical operations

FDA/ICH-GCP familiarity

Communication

Strategic planning

Education

Bachelor's degree in Life Sciences / Healthcare

Master's degree / PhD / PharmD / MD (preferred)

Tools

Electronic TMF systems

Job description

Experis is seeking an Associate Director of Clinical Ops (TMF) in Bethesda, MD. The role leads TMF strategy, governance, inspection readiness, and quality oversight across a global portfolio, with 2 days onsite and 3 days remote.

The candidate will manage TMF operations, ensure regulatory compliance (FDA/ICH-GCP), and drive improvements across multiple therapeutic areas, while mentoring a growing team in a hybrid work setting.