Senior TMF Strategy & Clinical Ops Leader

ManpowerGroup; Bethesda (MD); Híbrido; USD 130 000 - 155 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work model

Competitive compensation

Resumo da oferta

ManpowerGroup's Experis division is seeking an Associate Director of Clinical Operations - TMF to provide strategic TMF leadership and oversight across a global portfolio of clinical programs.

Based in Bethesda, MD, the role offers hybrid work (2 onsite days, 3 remote) and partners with cross-functional teams to ensure FDA/ICH-GCP compliance, timely TMF delivery, and strong sponsor engagement.

Qualificações

• Bachelor's degree in Life Sciences, Healthcare, or related field.
• 10+ years in pharma/CRO/clinical research; CRO experience preferred.
• 6+ years leading TMF strategy, operations, and teams.
• Strong TMF knowledge, FDA/ICH-GCP, inspection readiness.
• Excellent communication and stakeholder management.
• Experience leading diverse clinical programs.

Responsabilidades

• Lead TMF strategy, governance, and inspection readiness initiatives.
• Ensure TMF documentation is complete, accurate, and timely.
• Develop TMF plans, indices, filing structures, and study docs.
• Serve as senior TMF SME to leadership and external stakeholders.
• Scale TMF operations across a growing clinical portfolio.
• Provide oversight of TMF project management and filing processes.
• Support complex programs across multiple therapeutic areas.
• Manage study deliverables, timelines, budgets, risks, and metrics.
• Collaborate in a matrixed environment with cross-functional teams.
• Ensure adherence to FDA regulations, ICH-GCP, and quality standards.
• Drive SOPs, CAPA, and quality improvements; monitor KPIs.
• Support audits/inspections and related readiness activities.
• Directly manage TMF staff and oversee resource allocation.

Conhecimentos

TMF leadership

Regulatory knowledge

Stakeholder management

Team leadership

Clinical operations

Formação académica

Bachelor's degree in Life Sciences

Master's degree (preferred)

PhD/MD (preferred)

Ferramentas

Electronic TMF systems

Clinical technology platforms

Descrição da oferta de emprego

ManpowerGroup's Experis division is seeking an Associate Director of Clinical Operations - TMF to provide strategic TMF leadership and oversight across a global portfolio of clinical programs.

Based in Bethesda, MD, the role offers hybrid work (2 onsite days, 3 remote) and partners with cross-functional teams to ensure FDA/ICH-GCP compliance, timely TMF delivery, and strong sponsor engagement.