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Clinical Trial and Clinical Supplies Assistant (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Support
Projektbeschreibung
REFERENZNUMMER:
242511/11
IHRE AUFGABEN:
-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
IHRE QUALIFIKATIONEN:
-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
WEITERE QUALIFIKATIONEN:
Clinical trial assistant
242511/11
IHRE AUFGABEN:
-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
IHRE QUALIFIKATIONEN:
-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
WEITERE QUALIFIKATIONEN:
Clinical trial assistant
Projektdetails
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
-
Kategorie:
Sonstiges