Clinical Supply Manager

vor 1 Woche

Allschwil, Basel-Land, Schweiz Alentis Therapeutics AG Vollzeit
Reporting to Senior Project Director


Position Summary The Clinical Supply Manager is accountable for management, coordination and efficient on-time delivery of trial medication (including IMP= Investigational Medicinal Product, Placebo, Standard of Care and clinical ancillaries) supply for global clinical trials to enable the fulfillment of company milestones (FPD=first patient dosed).

The Clinical Supply Manager's responsibilities include demand forecasting, resupply planning, label design, packaging, distribution, quarantining/recall of IMP in case of issues (with collaboration of QA), destruction, drug reconciliation and active contribution to clinical documents, like the pharmacy manual.


Responsibilities:

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 setup in coordination with clinical team
  • Manage trial medication inventory and anticipate resupply 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:

  • 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 document 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

Documentation management:

  • According to the trial design, request (as appropriate), review and coordinate approval of external vendor quotes
  • File and archive trial specific document and GMP records (IMP batch release) and related GCP documents according to internal document 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 stability studies

Qualification:

  • 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

Anticipated salary range: 40-45K€ approximately depending on level of experience

Work location:
Home Based France, contract with Alentis Strasbourg office

Work permit:
EC nationality or adequate work permit

About Alentis:


Alentis' lead therapeutic program, ALE.F02, has finished recruitment into a Ph1a study in healthy volunteers and is currently being developed for the treatment of advanced fibrotic diseases.

ALE.C04 will enter clinical studies in oncology in 2023.

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