Clinical Trial Administrator (f/m/d)

GULP Information Services GmbH

Biberach an der Riß

On-site

EUR 50,000 - 70,000

Full time

14 days+

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Job summary

Gulp Ag in Germany seeks a clinical trial administrator to support planning, management and steering of timelines, costs and scope for global clinical trial activities in the supply chain area. You will assist the CTSU trial team within a matrix structure and help prepare documentation and meetings with clear action points.

The role requires experience in pharma, strong English skills, and willingness to travel, with familiarity in systems like BIRDS and various workflow tools.

Qualifications

  • Bachelor's degree with some years of experience.
  • Relevant experience in the pharmaceutical industry.
  • Basic project management skills.
  • Broad and thorough knowledge of applicable US and EU regulations and other international regulations.
  • Strong problem solving capabilities and encourage the implementation of 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 (e.g. Microsoft Office 365, Project Management Software).
  • Ability to present projects/status reports to different audiences.
  • Very good to fluent in English, spoken and written.
  • Willingness to travel.

Responsibilities

  • Support planning, managing and steering timelines, costs and scope of Trial Teams for global supply chain activities for assigned clinical trials, including highly complex trials.
  • Support the autonomous management of the CTSU trial team within the matrix structure.
  • Support CTS preparation documentation.
  • Support team meetings, minutes with action points and responsibilities.
  • Support of systems like BIRDS administration and workflows, Focus entries/CES entries, AC Evaluation coordination, AC Ordering, MLT drafting prior to TrM review/approval, GTL maintenance.
  • Support manual shipping requests for bulk shipments, stability samples and sampling documentation for Investigational Medicinal Products.

Education

Bachelor's degree

Tools

Microsoft Office 365
Project Management Software

Job description

Time for change – time for a new job! Are you a clinical trial administrator and looking for a new professional challenge in a pharmaceutical company? Then stop searching! We offer the job you are looking for: We offer a secure job, fair compensation and exciting new tasks at an attractive company in Biberach. We welcome applications from all suitably qualified persons regardless of any disabilities. Support of planning, managing and steering of timelines, costs and scope of Trial Teams for agreed deliverables of global supply chain activities for assigned clinical trials, including highly complex trials Responsible to support Trial Managers for the autonomous management of the CTSU trial team within the matrix structure Support of CTS preparation documentation Support of team meetings, minutes with action points and responsibilities Support of different systems like 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 etc. Support manual shipping requests for bulk shipments, stability samples and sampling documentation for Investigational Medicinal Products

  • Bachelor's degree with some 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 internationalregulations
  • Strong problem solving capabilities and encouragethe implementation of 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 andeffective manner
  • Strongcomputerskills(e.g. Microsoft Office 365, Project Management Software)
  • Ability to present projects/status reports to different audiences
  • Very good to fluent in English, spoken and written
  • Willingness to travel
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