Senior Manager, Study Start Up – FSP

🕒 vor 4 Tagen

🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🟠 Senior

👔 Manager

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

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Parexel

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1983

⚕️ Krankenversicherung

🧬 Biotechnologie

💊 Pharmazie

💰 Venture Round im 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel gehört zu den weltweit größten Auftragsforschungsinstituten (CROs) und bietet umfassende Services für den gesamten klinischen Entwicklungsprozess von Phase I bis IV. Das Unternehmen ist spezialisiert auf Portfolio-Management, Studienmanagement, Regulatory-Strategie, Market Access und Lifecycle-Management für Biopharmazeutika. Ziel von Parexel ist es, lebensverändernde Arzneimittel mithilfe seiner klinischen, regulatorischen und therapeutischen Expertise schneller auf den Markt zu bringen. Mit einem globalen Team von über 21. 000 Fachkräften integriert Parexel Patientenperspektiven und innovative Studiendesigns, um Therapien in Indikationsgebieten wie Onkologie, Neurowissenschaften, seltene Erkrankungen und mehr zu entwickeln. Im Fokus stehen patientenzentrierte und effiziente klinische Studien.

Beschreibung

• The Senior Manager, Study Start-up partners closely with the Clinical Operations study team leading global study start-up and site activation activities in Phase I-III and real-world evidence clinical trials. • This team member will also partner closely with CRO teams, internal study stakeholders, KOLs, external vendors, and site networks to drive top quality, best in class delivery, acceleration and optimization of study start-up, site activation and enrollment milestones. • The Senior Manager, Study Start-up provides direct oversight, direction, and support beginning with early study planning, country and site selection, data-driven scenario planning, and enrollment forecasting to ensure predictable and consistent delivery. • The Senior Manager, Study Start-up will oversee and ensure the delivery of global (end-to-end) study startup activities (strategy, plans, activities, timelines, and synthesis of study startup insights and presentation to study teams) at program/study level. • Create project plans for efficient implementation and oversight of appropriate processes, tools, and technologies to accelerate start-up activities. • Lead successful study and site activation oversight by removing complexity, conducting proactive risk mitigation, and removing obstacles for sites to successfully activate within study and corporate objectives. • The Manager, Study Start-up excels in project management, organizational, and communication skills to clearly share best practices with study teams, CROs, and internal stakeholders across the Clinical Operations organization to deliver consistent application of these practices.

🎯 Anforderungen

• Bachelor’s Degree in Science or related discipline required. • Significant (8+ years) previous experience gained with a CRO or biopharmaceutical company working on multinational clinical studies. • Considerable (5+ years) managing operational aspects of clinical studies. • Significant experience in leading global study start-up and site activation activities is required. • Must have experience working with external CROs and cross functional teams. • Broad-based experience in clinical development including clinical trial conduct, Study Start-up and feasibility, country and site selection and patient retention and recruitment. • Knowledge of GCP and a good understanding of the processes associated with clinical operations, study management and monitoring, and local regulatory requirements.

🏖️ Vorteile

• health insurance • retirement plans • paid time off • flexible work arrangements • professional development