O pozici
Study Manager ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Co budeš dělat
- In this role you will work in close partnership with the Global PM and Global Trial Managers on end-to-end operational study delivery activities, from study setup to study archival.
- Monitoring study conduct and progress, identifying, resolving and escalating risks/issues.
- Support Global PMs in CRO oversight, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties
- Oversight of Project Specialists activities and ensuring completeness of internal systems/databases/tracing tools and project plans.
- Facilitating and maintaining interactions and meetings with internal and external partners (including CROs and third-party vendors) to ensure the successful delivery of assigned studies
- Vendor management
- Coordinating study-related activities and overseeing study team's communication
- Overseeing delivery of clinical supplies, investigational products and all study materials
- Data oversight to ensure the study is inspection ready at all times, including oversight of eTMF completeness
- Overseeing of budget tracking – managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the Global PM.
Koho hledáme
- At least 3+ years of relevant work experience in a pharmaceutical/scientific environment.
- Knowledge of clinical trials, drug development process.
- Strong knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards.
- Experience in using Trial Master File industry accepted standard.
- Project management skills (preferably with analytical/financial skills) and good leadership skills.
- Excellent verbal and written communication in English.
- Proven experience in clinical operations and/or study management is required
- Strong communication and relationship building skills, including external service provider management
Benefity
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
