7 дней назад
Manager, Start Up
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager, Start Up (Clinical Research): Managing study start-up teams, staffing, resources, and timelines for clinical research programs across multiple countries with an accent on process harmonization, feasibility analysis, regulatory compliance, and people management. Focus on optimizing start-up operations, coordinating stakeholders, forecasting utilization, and maintaining quality across study start-up, maintenance, and close-out.
Location: Australia
Company
supports biotech, medtech, and specialty pharma companies in developing medicines, medical devices, and diagnostics through clinical research services.
What you will do
- Manage staffing, resources, utilization forecasts, and team transitions for new and active studies.
- Drive study start-up teams to meet project timelines while coordinating activities across multiple countries.
- Improve and harmonize processes for study start-up, essential document maintenance, maintenance, and close-out without compromising quality.
- Analyze metrics, feasibility data, costing, and out-of-scope activities to support planning and cost control.
- Manage, mentor, train, and evaluate direct reports, including performance objectives and career development.
- Support business development, client presentations, regulatory and operational procedures, and corporate initiatives.
Requirements
- Undergraduate degree or international equivalent in clinical, science, or health-related studies, a healthcare license, or equivalent work experience.
- At least 5 years of experience in the clinical research industry.
- At least 2 years of people management experience.
- Experience reviewing metrics and feasibility data, managing multiple deadlines, and working in a dynamic environment.
- Working knowledge of ICH/GCP regulations, FDA and European regulatory and ethics committee procedures, and national or local health systems.
- Fluent written and verbal English, with knowledge of web-based communication tools and project management principles.
Nice to have
- CRO, medical device, or pharmaceutical experience.
Culture & Benefits
- Opportunities for professional growth, skills development, and career pathing.
- Flexibility and balance to support personal and professional needs.
- Employee ideas and input influence working practices.
- Participation in global, cross-country clinical research initiatives.
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