Clinical Trial and Clinical Supplies Assistant (m/f)

Beschreibung

• Assists Global Lead Investigator Initiated Studies to meet IIS Project Office deliverables
• Submitted study protocols are reviewed by relevant stakeholders to internal processes and timelines
• Approved studies are managed to internal standards, timelines and budgets (approx. 60-70% of time)
• Provides Logistics support to the Clinical Operations Group (approx. 20-30% of time)
• Coordinates internal study review process
• Checks submitted study protocols and forms for completeness; follows up until submission is complete
• Archives relevant correspondence and documents
• Assists Legal with necessary information for the first contract draft and contract amendments
• Coordinates and tracks material shipments for supported studies
• Performs regular follow-up and tracking of study status
• Liaises with essential functions and Affiliates as needed to ensure smooth support to the study team
• Follow-up on study deliverables
• Escalates problems and learnings to study Office Lead, keeps them actively informed on status of studies assigned to them

• Has clinical operations and /or logistics work experience of at least one year in the Industry (Pharmaceutical/Diagnostics), e.g. CRA, CTA
• Has worked in a matrix environment, worked with cross functional experts to help deliver systems, processes, tools, studies
• Experience in an international work environment preferred
• Ability to negotiate as needed also with hierarchy to ensure compliance to internal standards and International Laws and Regulations governing clinical trials e.g. GCP
• Excellent organization, presentation & time management skills
• Ability to work independently, multi-tasking, building own support networks
• Flexible and willing to learn