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Study Delivery Specialist
2 months ago
We are seeking a highly skilled Study Delivery Specialist to join our team at ICON Strategic Solutions. As a key member of our Global Study Team, you will play a critical role in delivering clinical studies to time, cost, and quality.
Key Responsibilities- Study Delivery: Work closely with the Study Manager and/or Study Delivery Lead to ensure end-to-end operational study delivery activities are completed on time and within budget.
- Cross-Functional Collaboration: Collaborate with internal and external partners to manage clinical study activities, including in-house and outsourced studies across all phases and therapeutic areas.
- Risk Management: Identify, resolve, and escalate risks/issues that may impact study delivery to ensure quality, timeline, and budget objectives are met.
- Document Review and Development: Review key clinical documents, including protocols and informed consent forms, and lead the development of study plans for external and internal use.
- Vendor Management: Manage vendor relationships, oversee study-specific deliverables, and ensure timely delivery of activities delegated to third parties.
- Country Oversight: Act as a primary point of contact for country-specific activities, track recruitment progress, data completeness, and compliance, and oversee local budgets and protocol deviations.
- Communication and Team Management: Coordinate study-related activities, manage study team communication, and ensure effective stakeholder management.
- Supply Chain Management: Oversee the delivery of clinical supplies, investigational products, and study materials, and communicate issues/risks to continuity of supplies.
- Data Oversight: Ensure the study is inspection-ready at all times, including oversight of eTMF completeness and verification of quality.
- Budget Management: Manage task/change orders, expenses, and track updates to ensure consistency between systems and agreements.
- Education: Graduate/Bachelor's degree in life sciences or other related field.
- Experience: At least 1+ years of relevant work experience in a pharmaceutical/scientific environment, with a scientific background and knowledge of clinical trials and drug development process.
- Skills: Strong project management skills, excellent verbal and written communication, and ability to manage multiple competing priorities.
- Knowledge: Good knowledge of clinical trial regulatory requirements, including GCP and ICH guidelines, and ability to think independently and analyze problems systematically.
