Study Delivery Manager

2 days ago

Canada Home Instead Woodland Hills Full time
Study Delivery Manager Job Description

As a Study Delivery Manager at ICON, you will play a key role in delivering clinical studies to time, cost, and quality. You will be responsible for overseeing the end-to-end operational study delivery activities, from study setup to study archival, with a focus on setting up, maintaining, and ensuring completeness of internal systems, databases, tracking tools, and project plans.

Key Responsibilities:
  • Work closely with the Study Delivery Lead to ensure successful study delivery, providing subject matter expertise across key processes and systems throughout the life cycle of the study.
  • Monitor study conduct and progress, identifying, resolving, and escalating risks/issues that may impact delivery of the study to the necessary quality, timeline, and budget objectives.
  • Review key clinical documents, including the Protocol and Informed Consent Forms, and lead the development of study plans for external and internal use in assigned studies.
  • Facilitate and maintain interactions and meetings with internal and external partners to ensure the successful delivery of assigned studies.
  • Manage vendor relationships and oversee study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties.
  • Coordinate study-related activities and manage study team communication, including meetings, info-spaces, newsletters, action logs, communication plans, and team lists.
  • Oversee the delivery of clinical supplies, investigational products, and all study materials provided by the client or external service providers.
  • Ensure the study is inspection-ready at all times, including oversight of eTMF completeness and verification of quality.
  • Manage budgets, including Task/Change Orders, expenses, tracking updates, and checking consistency between systems and agreements.
Requirements:
  • 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.
  • Knowledge of clinical trials, drug development process, ICH-GCP, clinical study delivery process, and industry standards.
  • Strong project management skills, good leadership skills, and excellent verbal and written communication.
  • Excellent communication and relationship-building skills, including external service provider management skills.
What ICON Offers:
  • A competitive salary and benefits package.
  • A range of health insurance offerings to suit your needs.
  • Competitive retirement planning offerings.
  • A Global Employee Assistance Programme.
  • Life assurance.
  • Flexible country-specific optional benefits.

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