Solution Sales Specialist - ITSM - Cairo

Alentis Theutics is a clinical-stage biopharmaceutical company developing breakthrough treatments for cancer and fibrotic diseases.

Tasks

IMP and ancillary supply management:

• Plan, implement and execute the strategy for trial medication and ancillary supply in collaboration with clinical and CMC teams
• Manage Standard of Care and ancillary supply purchase activities for clinical trials when supplies are centralized at CMO depot
• Conceptualize packaging design and blinding setup
• Prepare distribution set-up in coordination with clinical team
• Manage trial medication inventory and anticipate re-supply needs in collaboration with CMC team
• Collaborate with external stakeholders, including logistics vendors, to solve issues related to supply
• Act as main contact for labelling and packaging vendors and with clinical sites for topics related to trial supplies
• In case of identified issues with the selected vendor, prepare a request for proposal and lead vendor selection process

Vendor management:

• Manage verbal (regular TC) and written (email) communication with external vendors to ensure project timelines
• Clearly communicate the deadline for various activities / delivery to the vendors
• Supervise outsourced labelling/packaging and distribution operations
• Monitor the performance of the external vendors towards their respective delivery and initiate improvement/mitigation plans as necessary
• Prepare and approve, in accordance with the related SOP, the Master Label Text according to relevant regulation
• Review and approve labelling/packaging records and trial specific doent in accordance with the related SOP
• Coordinate IMP and ancillary distribution (manually and/or via the IRT system)
• Monitor drug reconciliation, recall (with collaboration of QA)/quarantine, return and destruction of IMP
• Monitor import/export operations on IMP and ancillary supply until delivery at site
• Report progress and project updates to the line manager on regular basis via email or regular TC

Doentation management:

• According to the trial design, request (as appropriate), review and coordinate approval of external vendor quotes
• File and archive trial specific doent and GMP records (IMP batch release) and related GCP doents according to internal doent management system and Trial Master File
• Draft Pharmacy Manual
• Review and approve external vendor invoices according to project progress status

Quality:

• In collaboration with GMP / GCP QA and CMC teams, lead the evaluation of deviations which will occur during the storage and/or transfer of the supplies to the clinical sites and archive records as per internal SOP
• In collaboration with CMC team, manage the extension of the expiry dates of IMP according to the ongoing ility studies

Requirements

• Experience of > 5 years involved in Supply chain/Logistics activities in clinical trials
• Extensive experience in project management and leadership in Clinical Supply Management
• Knowledge and understanding of GMP and GCP regulations as well as other company related regulatory requirements