Responsibilities
* Ensure timely delivery of clinical trial supplies for assigned projects based on input from CMC and CTT
* Attend study kick-off meetings and elaborate the overall supply plan
* Develop the most suitable packaging solution
* Consider supply risk management in study planning
* Coordinate activities for completion of primary and secondary packaging
* Develop compliant label text and print booklets/labels
* Generate a material list taking into consideration the pack types and blinded status of the study
* Participate in the IRT setup, complete CTS specific documentation, set up should take into consideration study specific requirements, clinical trial supply expiry
Clinical Trial Distribution
* Develop a distribution plan with the external service utilizing the best most efficient distribution network in terms of timelines, quality, and cost
* Select the most appropriate carrier option for the clinical trial supplies
* Ensure all relevant distribution documentation is completed in advance including transport conditions and available to the CMO
* Complete and review import licenses, proforma invoices where appropriate
* Provide the study team CROs responsible for importation, quantities required for specific countries
Clinical Trial Returns / Destruction and Close Out
* Complete returns process with the external service provider
* Provide complete details to the study team
* Complete destruction at the earliest available time
* Receive certificates of destruction
Documentation
* Set up binder / TMF and eTMF for each clinical study
* Maintain binder throughout the duration of the study
* Close binder and provide to the relevant clinical team for long-term storage
Communication
* Ensure excellent communication between all stakeholders
* Present the overall clinical supply program to the CMC team
* Communicate and escalate any challenges or potential supply issues to the team leader of CPCTS and where appropriate CMC / CTT
Commercial Packaging
* Part of Commercial image definition team, with representatives from CMC, life cycle, DRA, QA TRA, and marketing
* Work to define the primary and secondary packaging requirement for the commercialization of the product
* Single point of contact of packaging suppliers, contract packagers, and packaging test laboratories
* Assess packaging technical changes and impact on overall product quality
* Create a registration packaging plan that includes all relevant activities and is in collaboration with CMC Team
Artwork
* Provide mock-ups to DRA for submission
* Provide the technical approval of the final artwork
* Provide fully approved artworks to the CMO for printing
Qualifications and Experience:
* Relevant working/residency permit or Swiss/EU-Citizenship required
* University degree or equivalent working experience in life sciences
* At least 3 or more years’ experience in the field of Commercial packaging or Clinical Trial Supply
* Knowledge of the relevant international GMP, GDP, GCP regulations
Location: Commercial And Trial • Basel and NW Switzerland, CH
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