Commercial Packaging and Clinical Trial Supplies Manager
vor 2 Wochen
- 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
- 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
- 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
- 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
- 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
- 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
- Provide mock-ups to DRA for submission
- Provide the technical approval of the final artwork
- Provide fully approved artworks to the CMO for printing
- 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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