Senior Director, TMF Services

🕒 Junho 25

🏖️ New Jersey, North Carolina, +1 estados a mais – Remoto

🏖️ New Jersey – Remote 🌲 North Carolina – Remote 🔔 Pennsylvania – Remote

⏰ Tempo Integral

🟠 Sênior

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TransPerfect

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

💼 Consultoria

⚖️ Jurídico

📣 Marketing

Consulting • Legal • Marketing

A TransPerfect é uma empresa global de linguagens e tecnologia que oferece serviços de tradução, localização, interpretação e conteúdo, combinados com ferramentas de software e inteligência artificial, como a plataforma de gerenciamento de tradução GlobalLink. Oferece marketing multilíngue, suporte regulatório nas áreas jurídica e de ciências da vida, serviços de contact center/BPO, localização de multimídia e soluções para globalização de sites, softwares e aplicativos. A TransPerfect atende grandes empresas e clientes da Fortune 500 em dezenas de indústrias e suporta conteúdo em mais de 200 idiomas.

Descrição

• Partner with executive leadership to develop annual business plans, revenue targets, and service line roadmap • Support business development to identify, pursue, and close new business opportunities including new client relationships, expanded scopes of work, and strategic partnerships • Own Profit & Loss (P&L) accountability for the divisions TMF Services practice, driving profitability through efficient delivery models and pricing strategy • Continuously evaluate and implement best-in-class tools and workflows for eTMF management, TMF record quality, and inspection readiness • Establish scalable delivery frameworks and quality standards across client engagements • Monitor industry trends (regulatory guidance, technology evolution, competitive landscape) and translate insights into service improvements • Revise, implement and monitor departmental compliance with SOPs • Champion the adoption of AI technologies, automation, and digital tools to enhance team productivity and client outcomes • Serve as an executive sponsor for key client accounts, ensuring high levels of satisfaction, retention, and growth • Oversee the successful delivery of the TMF Services portfolio, ensuring projects meet quality, timeline, budget, and compliance objectives • Build trusted advisor relationships with client stakeholders at the director and C-suite level • Ensure team members meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan • Serve as a visible spokesperson and subject matter expert for the company in the eTMF and clinical operations space • Represent the organization as a thought leader and subject matter expert through industry conferences, publications, webinars, and professional networks • Build and maintain a strong external network with sponsors, CROs, technology vendors, and industry associations • Recruit, develop, and lead a high-performing team while fostering a culture of accountability, collaboration, and continuous improvement • Collaborate cross-functionally with commercial, technology, and operational teams to achieve strategic business objectives • Complete all other tasks deemed appropriate for the role as assigned by the manager/supervisor

🎯 Requisitos

• Minimum Bachelor's degree or equivalent in life sciences, health sciences, or related field • At least 12 years of progressive experience in clinical operations, TMF, or clinical records management within a CRO, sponsor company, or clinical services provider • Minimum of 10 years of supervisory/management experience • Strong understanding of clinical trial processes and clinical records management operations • Proven experience presenting, speaking, or publishing in industry forums and professional settings • Demonstrated success in leading and scaling teams in fast-paced, client-facing environments • Demonstrated expertise in Trial Master File (TMF) strategy, eTMF platforms (e.g., Veeva Vault, TI, Wingspan, Medidata etc.), and supporting TMF inspection readiness • Strong knowledge of applicable regulations and guidance: ICH E6(R2/R3), FDA 21 CFR Part 11, EMA TMF guidelines, CDISC TMF Reference Model • Strong understanding of drug development and clinical trials operations • Proven ability to navigate ambiguity and successfully build and scale processes, teams, and service offerings. • Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint) • Outstanding verbal and written and interpersonal communication skills, with strong active listening abilities. • Strong analytical, problem-solving, and critical-thinking skills • Ability to work effectively in a global, cross-functional environment with internal and external stakeholders • Willingness to travel as required

🏖️ Benefícios

• Career growth opportunities • Environment where ideas are shared • Support for continuous dialogue with management