Clinical Study Manager

3 days ago

Canada ICON Full time
About the Role

We are seeking a highly skilled and experienced 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
  • Study Delivery
    • Work closely with the Study Delivery Lead to ensure the successful delivery of clinical studies.
    • Oversee the setup, maintenance, and completeness of internal systems, databases, and tracking tools.
    • Ensure that all study-related activities are completed on time and within budget.
  • Clinical Study Management
    • Work cross-functionally with internal and external partners to manage clinical study activities.
    • Develop and implement study plans, including monitoring plans, vendor management plans, and risk management plans.
    • Ensure that all clinical documents, including protocols and informed consent forms, are reviewed and approved.
  • Risk Management
    • Identify, resolve, and escalate risks and issues that may impact study delivery.
    • Develop and implement risk management plans to mitigate potential risks.
  • Vendor Management
    • Manage vendor relationships and ensure that all vendor deliverables are met.
    • Oversee the development and implementation of vendor management plans.
  • Country Oversight
    • Act as a primary point of contact for country-specific activities.
    • Track recruitment progress, data completeness, and compliance.
    • Oversee protocol deviations, risks, regulatory approvals, and import license status.
  • Communication and Collaboration
    • Coordinate study-related activities and manage team communication.
    • Facilitate and lead cross-functional meetings and ensure effective stakeholder management.
  • Quality and Compliance
    • Ensure that all study-related activities are conducted in accordance with regulatory requirements and industry standards.
    • Oversee the development and implementation of quality management plans.
  • Financial Management
    • Manage study budgets and ensure that all expenses are tracked and reported.
    • Develop and implement financial management plans to ensure that study budgets are met.
Requirements
  • Education
    • University degree or equivalent in a medical or biological science or discipline associated with clinical studies.
  • Experience
    • At least 3+ years of relevant work experience in a pharmaceutical or scientific environment.
    • Knowledge of clinical trials, drug development process, and ICH-GCP.
    • Excellent project management skills and good leadership skills.
    • Excellent verbal and written communication skills.
  • Skills
    • Excellent knowledge of clinical trial regulatory requirements and industry standards.
    • Ability to manage multiple competing priorities and think independently.
    • Logical and analytical thinking, with a focus on quality and attention to detail.
    • Excellent stakeholder management and communication skills.
What We Offer

We offer a competitive salary and a range of benefits, including annual leave entitlements, health insurance, retirement planning, and flexible country-specific optional benefits.

We are committed to providing an inclusive and accessible environment for all candidates and employees. We welcome applications from diverse candidates and are proud to be an equal opportunities employer.

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