Global Clinical Study Coordinator

4 weeks ago

Canada ICON Strategic Solutions Full time

Position Overview

ICON Strategic Solutions is a premier organization specializing in healthcare intelligence and clinical research. We are dedicated to advancing clinical research by providing outsourced services to pharmaceutical companies, biotechnology firms, medical device manufacturers, and governmental health organizations. With a patient-centric approach, we strive to expedite the development of innovative drugs and devices that enhance lives and improve health outcomes. Our workforce is our most valuable asset, embodying our culture and driving our success. At ICON, our team is motivated by a shared mission and a commitment to excellence.

Key Responsibilities:

  • Execute study management activities as per the agreed delegation from senior management.
  • Collaborate with internal specialists and external partners to oversee the successful delivery of both in-house and outsourced studies.
  • Lead the development of essential study documentation, including Informed Consent Forms and study-specific plans.
  • Facilitate effective communication with internal and external stakeholders to ensure timely, cost-effective, and high-quality study delivery.
  • Oversee the setup and ongoing management of third-party vendors.
  • Assist senior management with budget oversight, including initiating vendor contracts, generating purchase orders, and tracking expenditures against the approved budget.
  • Contribute to the preparation of data management documents and liaise with data management teams to ensure the accurate delivery of study data.
  • Support the organization and execution of internal and external meetings.
  • Ensure an adequate supply of study materials by coordinating with Clinical Supply Chain or external providers as necessary.
  • Proactively identify risks and issues, developing mitigation strategies and action plans as needed.
  • Ensure all study documentation under the Global Study Manager's purview is complete and meets quality standards in the Trial Master File.
  • Adhere to standard operating procedures, global processes, and applicable quality and compliance guidelines to maintain inspection readiness.
  • Engage in non-drug project initiatives aimed at process improvements and lead enhancement projects as agreed with management. May serve as a Subject Matter Expert for specific processes or systems within Study Management.

Qualifications:

  • A university degree or equivalent experience, preferably in medical or biological sciences or a related field in clinical research.
  • A minimum of 12 months of relevant experience in the pharmaceutical industry or clinical trials in a similar capacity.
  • Comprehensive knowledge of ICH-GCP and relevant regulatory and ethical standards in clinical and drug development.
  • Experience managing CAR-T studies focused on oncology is essential.
  • Strong organizational, time management, and analytical skills, with a keen attention to detail and the ability to manage multiple tasks in a dynamic environment.
  • Proven ability to work effectively in both team settings and independently.
  • Excellent verbal and written communication skills in English.
  • Ability to prioritize tasks effectively and demonstrate adaptability.
  • Demonstrated leadership capabilities.
  • Proficient in computer applications relevant to daily tasks.

Why Join ICON?

Our success is rooted in the expertise, capabilities, and quality of our team members. We are committed to fostering a culture of continuous learning, where you will be challenged with engaging work that contributes to your professional growth.

At ICON, we offer a comprehensive and competitive rewards package that includes not only a competitive base salary but also a variety of performance-based incentives and recognition programs. Our employee benefits, supportive policies, and wellness initiatives are designed to support you and your family throughout your career journey.

ICON, including its subsidiaries, is an equal opportunity employer committed to creating a diverse and inclusive workplace. We ensure that all qualified applicants receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

If you require reasonable accommodations due to a medical condition or disability during the application process or to perform essential job functions, please inform us.

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