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Global Clinical Delivery Manager

icon · Sofia

Ново
Senior 🇬🇧 English
ICH-GCP eTMF Trial Master File CSAP

Описание на позицията

About the role

ICON, a global healthcare intelligence and clinical research organisation, is looking for a Global Study Manager to support the coordination and management of clinical trials worldwide. The role contributes to the design, analysis and advancement of new treatments and therapies, and works in partnership with the Study Delivery Lead on end-to-end operational study delivery.

Key responsibilities

  • Deliver clinical studies on time, within budget and to quality, and oversee study eTMF completeness for inspection readiness
  • Work with the Study Delivery Lead on study setup to archival, maintaining internal systems, databases, tracking tools and project plans (CSAP)
  • Manage clinical study activities for in-house and outsourced studies across all phases and therapeutic areas, following the Study Team Operating Model and client procedures
  • Monitor study conduct and progress, identify and escalate risks affecting quality, timeline and budget
  • Review key clinical documents such as the protocol and informed consent forms, and lead the development of study plans (monitoring plan, vendor management plan, deviation and risk management plans, communication plan)
  • Facilitate meetings with internal partners (regulatory, local operations, quality assurance, monitors) and external partners (CROs, third-party vendors)
  • Manage vendors and oversee CROs, acting as primary point of contact for study-specific deliverables

Required profile

  • Bachelor's degree in a scientific or related field; advanced degree preferred
  • At least 5 years of experience in clinical research
  • 1-2 years as an Associate Project Manager in a CRO or pharma setting
  • Experience managing vendors and working with cross-functional teams
  • Legal right to work in the country where the role is based

Required skills

  • Excellent knowledge of ICH-GCP and clinical study delivery processes
  • Familiarity with key clinical trial systems and the Trial Master File
  • Project management skills, preferably with analytical and financial skills
  • Excellent English communication and relationship-building skills

What we offer

  • Competitive base salary and performance-related incentives
  • Health and wellbeing programmes, including medical, dental and vision coverage where applicable
  • Retirement and pension plans, life assurance and disability coverage
  • Employee assistance programmes and learning and development opportunities

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Source : ats:workday

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