Senior Director, TMF Services

🕒 vor 4 Monaten

🏖️ New Jersey, North Carolina, +1 weitere Bundesländer – Remote

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

⏰ Vollzeit

🟠 Senior

👔 Direktor

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

👻 Geisterscore 44%

Was es bedeutet: die Wahrscheinlichkeit, dass für diese Stelle niemand wirklich einstellt.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

Jetzt Bewerben

Ähnliche Remote-Jobs finden

TransPerfect

WebsiteLinkedInAlle Stellen

5001 - 10000 Mitarbeiter

💼 Beratung

⚖️ Rechtswesen

📣 Marketing

Consulting • Legal • Marketing

TransPerfect ist ein globales Sprach- und Technologieunternehmen, das Übersetzungs-, Lokalisierungs-, Dolmetsch- und Inhaltsdienste anbietet, kombiniert mit Software- und KI-gestützten Tools wie der GlobalLink Translation Management Plattform. Es bietet mehrsprachiges Marketing, rechtliche und regulatorische Unterstützung im Bereich Life-Sciences, Contact Center/BPO-Dienste, Multimedia-Lokalisierung sowie Lösungen für die Globalisierung von Webseiten, Software und Apps. TransPerfect bedient große Unternehmen und Fortune-500-Kunden aus dutzenden Branchen und unterstützt Inhalte in über 200 Sprachen.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

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

📊 Überprüfen Sie Ihre Lebenslauf-Bewertung für diese Stelle

Verbessern Sie Ihre Chancen auf ein Vorstellungsgespräch, indem Sie Ihre Lebenslauf-Bewertung vor der Bewerbung überprüfen.

Lebenslauf hochladen