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Clinical Study Manager for Network Services
2 months ago
We are seeking a highly skilled Clinical Study Manager to join our team at ICON. 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- Oversee the delivery of clinical studies, ensuring they are completed on time, within budget, and to the required quality standards.
- Work closely with the Study Delivery Lead to develop and implement study plans, ensuring they are aligned with business objectives.
- Manage and maintain relationships with internal and external partners, including CROs and third-party vendors.
- Monitor study conduct and progress, identifying and resolving risks and issues that may impact delivery.
- Develop and implement risk management plans, communication plans, and other study-specific plans to ensure successful study delivery.
- Oversee the management of clinical supplies, investigational products, and study materials, ensuring continuity of supplies and communicating issues to stakeholders.
- Ensure the study is inspection-ready at all times, including oversight of eTMF completeness and verification of quality.
- Manage study budgets, including task orders, expenses, and tracking updates, ensuring consistency between systems and agreements.
- Contribute to the development of business agility and embracing change, working closely with the Study Delivery Lead and other team members.
- University degree or equivalent in a medical or biological science or discipline associated with clinical studies.
- At least 3+ years of relevant work experience in a pharmaceutical/scientific environment.
- Excellent knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards.
- Strong project management skills, including analytical and financial skills, and good leadership skills.
- Excellent communication and relationship-building skills, including external service provider management skills.
- Ability to manage multiple competing priorities, with good planning, time management, and prioritization skills.
- Ability to think independently, analyze and solve problems systematically and creatively, and take a risk-based approach.
- Quality mindset, critical sense, attention to detail, effective training, and mentoring skills.
- Very good understanding of the principles of project planning and management.
- Knowledge of project finance and accounting principles.
- Excellent comprehension of Microsoft Office tools, including Excel, PowerPoint, Word, Outlook, etc.
- Knowledge of advanced Excel, timelines/budget tracking systems, and clinical trial management systems.
- Excellent stakeholder management and communication skills, including oral and written communication.
- Ability to influence and manage stakeholders at all levels of the organization, facilitate and lead cross-functional meetings, challenge status quo, and be comfortable in a mediator role.
At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. Our rich diversity makes us more innovative, which helps us better serve our people, patients, customers, and our communities.
We are an equal opportunities employer and welcome applications from all qualified candidates. If you need a reasonable accommodation for any part of the application process, please let us know through the form below.
