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 IRT systems, ensuring that user requirements and specifications are met.
Your Background: Education & Experience - BS/BA or equivalent in operations, life sciences, or a health-related field.
- Minimum of 3 years of experience in the pharmaceutical/biotechnology industry, with a focus on clinical supply chain, clinical trial material management, or related areas.
- Experience with primary and secondary packaging and labeling processes for investigational products.
- Experience with distribution, recall processes, and regulatory requirements for clinical trial materials.
Skills & Knowledge - Strong understanding of cGMPs, FDA, and EU regulations governing clinical trials.
- Experience managing CMO contracts and vendor relationships.
- Detail-oriented with a focus on process optimization and compliance.
- Excellent written and verbal communication skills, with the ability to collaborate effectively with cross-functional teams.
- Strong interpersonal skills, with the ability to diplomatically interact with senior management, external vendors, and clinical trial sites.
- Ability to prioritize tasks in a fast-paced, dynamic environment and manage multiple competing deadlines.
Preferred Qualifications- Previous experience in clinical supply chain roles within a biotechnology or pharmaceutical company.
- Familiarity with IRT or other clinical trial management systems.
Estimated Salary Range: [$99,000- $167,00].
The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate's education, experience, skills and location.
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