In this position, you report to the Clinical Trial Supplies Project Manager and are in charge of the management of supply chain activities for clinical trial supply materials, from IMP starting material, packaging materials, labels and booklets, auxiliary materials, and comparators to distribution of IMP kits.
You are responsible to facilitate the incoming goods processes as well as supporting the IMP distribution to global clinical trial sites or to local depots.
Your main tasks are the following :
In collaboration with internal logistics experts and Clinical Trial Supplies Project Manager, define the logistics strategy, to set up the logistics and distribution activities at a new, efficient internal IMP Packaging & Distribution site as per current standards
Evaluate, identify and select distributors and depots where needed.
Support Receipt, Pick and Pack, IMP Distribution to sites or depots, Returns, Rejects and Destruction, and ensure these activities are reflected in the available IT systems to kit level so that reports can be provided upon request
Perform the inspection and receipt of incoming materials
Perform consolidation of returns and rejects
Manage the inventory of all materials required for clinical supplies
Evaluate import and customs requirements for global sites and depots, and manage the activities to have the required documentation in place to allow IMP distribution as planned
Perform housekeeping activities and documentation as assigned by Clinical Trial Supplies Management Team at HQ, and by Clinical Trial Supplies Project Manager, or by internal manufacturing specialists
Ensure that all supplies are controlled and distributed in accordance with GMP, GCP and GDP regulations
Interact with the Clinical CRO and IRT (Interactive Response Technology) on supplies, replenishment, returns and destructions
Review and archive any blinded documentation until the end of the clinical study
For this role, we are looking for a flexible and efficient person bringing the following profile :
At least 3 years’ experience in the pharmaceutical clinical logistics operations, such as inventory control and logistics
Proven experience in managing the drug supply chain for global clinical trials, including
Hands-on experience in developing and managing integrated supply chain IT support systems (IRT)
Previous experience in managing clinical trial supplies distributors
Very good knowledge of GMP, GCP and GDP compliance requirements
Fluent in Portuguese and English both in oral and written conversation
You love the unexpected and feel comfortable in a work environment where changes happen constantly. You can work effectively under pressure and are used to evolving in a matrix organization, where communication is the key to a strong collaboration.
You want to take up a new challenge and to actively participate in our company development in Lisbon.