healthcare
Posted 5 days agoClinical & Ancillary Supplies Services
at Fortrea
On-site
Responsibilities
- Perform and coordinate label review and country translations according to set procedures for a global study.
- Support the development of project specific plans for the Clinical and Ancillary supply component of assigned studies.
- Represent Clinical and Ancillary supplies component for country(ies) in the region at client and internal project meetings.
- Review the protocol to confirm if Fortrea / other vendor can import all the supplies required.
- Coordinate and track shipments to sites required for each protocol as appropriate in the region.
- Update the Importation Process for each respective country in the region as needed.
- Perform administrative tasks required during study start up activities (e.g., word processing, assembly of study documents, mass mailings, filing, faxing/photocopying).
- Manage the country / regional drug supply vendor activities as applicable.
- Oversee importation logistics and document exchange to ensure smooth clinical supply transportation arrangements are agreed and set up.
- Develop, review, and approve drug supply labels as applicable.
- Coordinate ancillary supply logistics with various vendors or internal team.
- Independently research and evaluate proposal request from clients in all therapeutic areas within agreed timeframes.
- Conduct QC of documents as required by the process.
- Undertake literature and internet searches as required.
- Mentor other team members.
- Understand and follow project specific and Fortrea policies and procedures.
Requirements
- Work with GRS on obtaining, understanding, and interpreting country-specific
- requirements and regulations for the importation of CT supplies.
- Qualifications (Minimum Required): University/College degree (life science preferred), or certification in a related allied health profession English level: Advanced/ fluent
- experience in a Global pharmaceutical company/CRO, including at least 1 year of clinical and ancillary supplies management responsibility.
- Advanced English level Working knowledge of ICH, FDA, GMP and other applicable regulations/guidelines; familiarity with clinical supply related documents.