Senior Director, TMF Services

🕒 il y a 3 mois

🏖️ New Jersey, North Carolina, +1 états de plus – Distant

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

⏰ Temps Plein

🟠 Senior

👔 Directeur

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 32%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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TransPerfect

Site WebLinkedInTous les Emplois

5001 - 10000 employés

💼 Conseil

⚖️ Juridique

📣 Marketing

Consulting • Legal • Marketing

TransPerfect est une entreprise mondiale spécialisée dans les technologies linguistiques, offrant des services de traduction, de localisation, d'interprétation et de gestion de contenu, associés à des outils logiciels et d'intelligence artificielle comme la plateforme de gestion de traduction GlobalLink. Nous proposons des services de marketing multilingue, un support réglementaire juridique et pour les sciences de la vie, des services de centre de contact/BPO, de localisation multimédia, et des solutions pour la mondialisation de sites web, logiciels et applications. TransPerfect sert les grandes entreprises et les clients du Fortune 500 à travers des dizaines d'industries et prend en charge le contenu dans plus de 200 langues.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

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