Study Delivery Specialist

2 weeks ago

Emelle Alabama, United States Pharmaceutical Research Associates, Inc Full time
Job Description

We are seeking a highly skilled Study Delivery Specialist to join our team at Pharmaceutical Research Associates, Inc. in Hungary.

About the Role:

  • As a Study Delivery Specialist, you will be responsible for end-to-end operational study delivery, focusing on completion and maintenance of internal systems/databases/tracking tools and project plans.
  • You will support the study team in study coordination activities and administrative tasks, ensuring inspection readiness and compliance with regulatory requirements.
  • Depending on your experience and expertise, you may contribute to the development/review of study documents, vendor management, and cooperation with Local Operating Companies (LOCs) and other internal functions.

Key Responsibilities:

  • Setting up and maintaining systems and tracking tools to ensure quality, consistency, and integration of study data.
  • Supporting the Study Delivery Lead in quality and data oversight to ensure inspection/audit readiness, including oversight of eTMF completeness.
  • Managing the study team's communication, including meetings, info-spaces, newsletters, action logs, communication plans, and team lists.
  • Coordinating the study budget, managing expenses, tracking updates, and checking consistency between systems and agreements.

Requirements:

  • University Scientific Degree or other related field.
  • Graduate or Bachelor level with at least 1+ years of relevant working experience in pharmaceutical/scientific environment.
  • Scientific background and knowledge of clinical trials (including ICH-GCP) is an asset.
  • Foundation experience in clinical trial delivery, including processes, regulations, operational best practices, industry standards.

What We Offer:

  • A competitive salary and benefits package.
  • A range of health insurance offerings to suit your needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • A Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals.

At ICON, diversity, inclusion, and belonging are fundamental to our culture and values. We're proud of our diverse workforce and the work we've done to become a more inclusive organization.

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