Clinical Study Manager

7 hours ago

Canada ICON Full time
Job Summary

We are seeking a highly skilled Clinical Study Manager to join our team at ICON. As a key member of the Global Study Team, you will be responsible for delivering clinical studies to time, cost, and quality, ensuring inspection readiness, and driving continuous improvement initiatives.

Key Responsibilities
  • Oversee study eTMF completeness, including setup, periodic reviews, and following up on missing documents.
  • Work closely with the Study Delivery Lead on end-to-end operational study delivery activities, from study setup to study archival.
  • Collaborate with internal and external partners on clinical study management activities, ensuring compliance with Study Team Operating Model (STOM), current clinical study regulations, and procedures.
  • Monitor study conduct and progress, identifying, resolving, and escalating risks/issues that may impact delivery of the study.
  • Facilitate and maintain interactions and meetings with internal and external partners to ensure successful study delivery.
  • Manage vendor relationships, oversee study-specific deliverables, and ensure timely delivery of activities delegated to third parties.
  • Coordinate study-related activities, manage study team communication, and oversee delivery of clinical supplies and investigational products.
  • Ensure data oversight, ensuring the study is inspection ready at all times, and assure that all eTMF documents are complete and verified for quality.
  • Manage budget oversight, including Task/Change Orders, expenses, and tracking updates.
Requirements
  • University degree or equivalent in medical or biological science or a 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, good leadership skills, and excellent communication and relationship-building skills.
  • Ability to manage multiple competing priorities, think independently, and analyze and solve problems systematically and creatively.
  • Quality mindset, critical sense, attention to details, and effective training and mentoring skills.
What We Offer
  • Competitive compensation and benefits package.
  • Opportunities for professional growth and development.
  • Diverse and inclusive work environment.
  • Recognition and rewards for outstanding performance.

At ICON, we value diversity, inclusion, and belonging. We are an equal opportunities employer and welcome applications from all qualified candidates.

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