Clinical Trial Coordinator

Vor 7 Tagen

Biberach an der Riß, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

Job Summary

GULP – experts united is seeking a highly skilled Clinical Trial Administrator to support the planning, management, and steering of timelines, costs, and scope of Trial Teams for agreed deliverables of global supply chain activities for assigned clinical trials.

Key Responsibilities

  • Support Trial Managers in the autonomous management of the CTSU trial team within the matrix structure.
  • Prepare and maintain CTS preparation documentation.
  • Coordinate team meetings, minutes with action points, and responsibilities.
  • Manage different systems, including BIRDS (BI System) administration and workflows, Focus entries/updates, CES entries/updates, AC Evaluation coordination, AC Ordering, MLT drafting prior to TrM review/approval, GTL maintenance, manual release form, and manual shipping request for bulk shipments, stability samples, and sampling documentation for Investigational Medicinal Products.

Requirements

  • Bachelor's Degree with several years of experience.
  • Relevant experience in the Pharmaceutical industry.
  • Basic project management skills.
  • Broad and thorough knowledge and understanding of applicable US and EU regulations and other international regulations.
  • Strong problem-solving capabilities and the ability to implement innovative approaches, new technologies, and strategies to support the successful completion of supply chain activities.
  • Proven ability to drive results in a changing environment and to discuss and present proposals in a concise and effective manner.
  • Strong computer skills, including Microsoft Office 365 and Project Management Software.
  • Ability to present projects and status reports to different audiences.
  • Very good to fluent in English, spoken and written.
  • Excellent written and verbal communication skills.
  • Willingness to travel.

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