Manager, Clinical Supply Chain

The Opportunity: You will be responsible for overseeing the supply chain operations for clinical trials, including the management of investigational medicinal products (IMPs) and comparators. This role will be pivotal in ensuring that study sites are supplied with the necessary products on time and in full compliance with regulatory requirements. The ideal candidate will have a strong analytical, organizational, and communication skill set, with the ability to manage multiple tasks in a dynamic, fast-paced environment.

Your Role: · Monitor IP inventory levels at depots and clinical trial sites to proactively manage supply chain risks and prevent any interruptions to study timelines. · Coordinate the import, export, and transportation of clinical trial materials (CTM) to ensure timely delivery and compliance with regulatory requirements. · Track shipments to and from clinical sites, ensuring adherence to timelines and quality standards. · Support Author development and approval of English label text for investigational drugs, translations, and approval of final label design while ensuring compliance with regulatory and quality standards. · Oversee the packaging and labeling processes at clinical supply vendors, reviewing and approving batch records. · Ensure proper storage conditions of investigational products at depots and clinical sites. · Review and disposition temperature excursions and develop strategies to minimize their impact. · Maintain audit-ready documentation for all clinical supply activities and ensure compliance with cGMPs and relevant FDA/EU regulations. · Track actual expenses vs PO’s & quotes vendors for packaging, labeling, and distribution services. · Facilitate communication and collaboration with internal teams (Clinical Operations, Regulatory, Quality) and external stakeholders (vendors, consultants) to ensure smooth execution of clinical supply activities. · Manage interactions with clinical trial sites regarding the return and destruction of investigational products. · Support User Acceptance Testing (UAT) for new or updated IXRS/IRT systems, ensuring that user requirements and specifications are met.

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