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Commercial Packaging and Clinical Trial Supplies Manager
For our client, an innovative and dynamic bio-pharmaceutical company covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, we are looking for a Commercial Packaging and Clinical Trial Supplies Manager for a 12-month contract (with possibility of extension) based in Basel area, Switzerland.
Main Responsibilities:
Clinical Trial Set up
* 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 utilising 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 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 duration of study
* Close binder and provide to 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 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 commercialisation 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
Serialisation
* Application manager responsibility
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
* Excellent English required
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.
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