We are seeking a highly experienced and organized Clinical Trial Supply Manager to oversee the management and execution of clinical trial supplies throughout their lifecycle.
This role involves coordinating the timely delivery, packaging, distribution, and destruction of clinical trial supplies while ensuring compliance with regulatory standards and efficient processes.
You will collaborate with the Clinical Management and CMC teams to develop comprehensive supply plans, manage supply risks, and handle logistics for primary and secondary packaging.
The Clinical Trial Distribution Plan must ensure efficient delivery with a focus on quality, cost, and timelines. You will also prepare documentation for importation, manage returns and destruction, and close the Trial Master File (TMF) for each study in a timely manner.
Jurisdictional Knowledge
You will contribute to the commercial packaging of the product by defining packaging requirements, managing relationships with suppliers, and ensuring regulatory approval of artwork and packaging.
Serilization and applying serial numbers are also part of this role.
Requirements
* Degree in life sciences
* At least 3 years of experience in clinical trial supply or commercial packaging
* Understanding of international GMP, GDP, and GCP regulations
* Strong communication and interpersonal skills
* Team-oriented approach