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Study Delivery Specialist
2 months ago
ICON Strategic Solutions is seeking a highly skilled and experienced Study Delivery Specialist to join our Global Study Team. As a key member of the team, you will be responsible for delivering clinical studies to time, cost, and quality, ensuring inspection readiness, and driving continuous improvement initiatives.
Key Responsibilities- Work closely with the Study Manager and/or Study Delivery Lead to oversee end-to-end operational study delivery activities, from study setup to study archival.
- Ensure the completeness and accuracy of internal systems, databases, and tracking tools, as well as project plans (CSAP).
- Collaborate with internal and external partners to manage clinical study activities, in accordance with Study Team Operating Model, current clinical study regulations, and procedures.
- Monitor study conduct and progress, identifying and resolving risks and issues that may impact delivery.
- Review key clinical documents, including protocols and informed consent forms, and lead the development of study plans.
- Facilitate and maintain interactions with internal and external partners to ensure successful study delivery.
- Manage vendor relationships and oversee CRO activities, ensuring timely delivery of delegated tasks.
- Oversee country-specific activities, including tracking recruitment progress, data completeness, and compliance.
- Coordinate study-related activities and manage team communication, including meetings, info-spaces, and action logs.
- Ensure the delivery of clinical supplies and investigational products, and communicate issues or risks to continuity of supplies.
- Oversee data quality and ensure the study is inspection-ready at all times, including eTMF completeness.
- Manage budgets and track expenses, ensuring consistency between systems and agreements.
- Graduate or Bachelor's degree in life sciences or a related field.
- At least 1+ years of relevant work experience in a pharmaceutical or scientific environment.
- Scientific background and knowledge of clinical trials, including ICH-GCP, and drug development process.
- Foundational knowledge of clinical study delivery process, including regulations, operational best practices, and industry standards.
- Strong project management skills, with analytical and financial skills.
- Excellent verbal and written communication skills.
- Good knowledge of clinical trial regulatory requirements, including GCP and ICH guidelines.
- Ability to manage multiple competing priorities, with good planning, time management, and prioritization skills.
- Logical and analytical thinking, with an inclination to spot patterns and outliers.
- Quality mindset, critical sense, attention to detail, and effective training skills.
- Basic knowledge of project finance and accounting principles.
- Excellent stakeholder management and communication skills.