Senior Clinical Trials Manager

🕒 vor 1 Tag

🏄 California – Remote

🏄 California – Remote

💵 $135.000 - $183.000 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Manager

Jetzt Bewerben

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T45 Labs

WebsiteLinkedInAlle Stellen

11 - 50 Mitarbeiter

Gegründet 2022

🤝 B2B

🧬 Biotechnologie

💸 Finanzen

B2B • Biotechnology • Finance

T45 Labs ist ein in Silicon Valley ansässiger Entwickler und Risikokapitalgeber, der die nächste Generation minimal-invasiver kardiovaskulärer Medizintechnologien entwickelt und finanziert. Es inkubiert und finanziert Portfoliogesellschaften, die an fortschrittlichen Therapien und Geräten arbeiten – darunter Nanopartikel-Dual-Drug-beschichtete Ballons, Koronarsinusreduzierer und drahtlose intravaskuläre Bildgebung – und konzentriert sich auf klinische Fortschritte, regulatorische Meilensteine und strategische Exits. Das Unternehmen kombiniert MedTech-Produktentwicklung, kommerzielle Strategie und Kapitalmarkterfahrung, um Unternehmen in Richtung Kommerzialisierung voranzutreiben.

Beschreibung

• Lead operational planning and execution of clinical studies from startup through study closeout. • Own study startup strategy and maintain accountability for site activation progress across all participating sites. • Develop and maintain study timelines, milestones, and operational deliverables. • Own enrollment forecasting, study metrics, and operational reporting. • Identify operational risks and implement mitigation plans to maintain study performance. • Ensure study execution remains aligned with protocol requirements, timelines, budgets, and business objectives. • Serve as the primary operational contact for CROs, vendors, consultants, and external study partners. • Manage vendor deliverables, timelines, communication, budgets, and performance. • Own study-level vendor oversight and operational accountability. • Maintain oversight of site budgets and contracts in collaboration with Clinical Affairs and study leadership. • Ensure operational activities remain aligned across vendors, sites, and internal stakeholders. • Maintain oversight of study documentation, TMF quality, and inspection readiness activities. • Ensure study conduct remains compliant with SOPs, GCP, FDA regulations, quality system requirements, and study plans. • Own study-level risk identification, issue escalation, and mitigation planning. • Maintain oversight of CAPA follow-up and resolution activities. • Drive resolution of study-level operational challenges. • Partner closely with Clinical Affairs, Regulatory, Quality, Data Management, Engineering, and other internal stakeholders. • Lead study team meetings and operational reviews. • Provide regular study updates, operational insights, enrollment forecasts, and risk assessments to leadership. • Drive alignment across internal teams, vendors, and clinical sites. • Ensure consistent execution of study processes across participating sites.

🎯 Anforderungen

• Bachelor’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related scientific discipline. • 7+ years of experience managing clinical studies within the medical device industry. • Experience with cardiovascular and catheter-based medical device clinical studies strongly preferred. • Demonstrated experience leading study-level clinical operations activities, including study startup, vendor management, enrollment forecasting, study metrics, and cross-functional execution. • Demonstrated experience managing clinical trial timelines, budgets, operational deliverables, and external vendors. • Demonstrated experience overseeing clinical studies from startup through study closeout. • Demonstrated understanding of FDA regulations, ICH/GCP, and clinical research operations. • Strong leadership, communication, organizational, and problem-solving skills. • Ability and willingness to travel up to 30% based on study and business needs.

🏖️ Vorteile

• Bonus opportunities • Equity • Company-sponsored benefits