- The Clinical and Ancillary Supplies Services Specialist II :
- Independantly support the delivery of the Clinical and Ancillary Supplies component of assigned studies within a region or for simple global study.
- Act as contact of study team during clinical and ancillary start up activities including input of the development of the Clinical trails supplies plan or clinical trial supply flow for a given group of countries in a region or within a region or for a simple global study.
- Perform and coordinate label review and country translations according to set procedure.
- Responsible for working with project team to ensure the required documents and processes related to supply management are communicated and obtained.
- Where appropriate be the key contact for importation logistics and document exchange to ensure smooth clinical supply transportation arrangements are agreed and set up.
- Provide consultancy with regard to clinical and ancillary supply distribution startegy for the assigned region.
- Responsible for maintenance of project specific clinical and ancillary supply logistics
- Work closely with drug and ancillary supply distribution, IVRS/ IRT and label translation vendors during the setup and maintenance of related logistics.
University degree in a related alllied health profession.
5 Years work experience in Clinical research including a strong working knowledge of the ICH - GCP guidelines and FDA, GMP regulations.