Global Supply Chain Coordinator
hace 3 semanas
The Clinical Study Supply Manager will play a crucial role in ensuring the timely and efficient supply of investigational medicinal products, auxiliary medical products, medical devices, electronic equipment, laboratory kits, and associated activities for clinical trials. This position involves coordinating import and export operations, handling customs clearance, and interacting with couriers, brokers, and customs authorities.
Key Responsibilities:
- Request, compile, complete, and/or review necessary documentation for import/export operations, including pro forma/commercial invoices and other relevant documents.
- Liaise with the clinical team to ensure country-specific requirements are met prior to study-related shipments.
- Coordinate study supply distribution to study sites and maintain regular tracking on shipment status and issues.
- Manage quality issues related to investigational products, such as recalls, temperature excursions, and product technical complaints.
- Attend study team meetings and teleconferences as needed to discuss logistics and supplies.
- Support document filing and maintain familiarity with ICH GCP, GxP, ICON SOPs, and applicable country legislation.
- Contact study sites to confirm missing equipment information and inform the CTM of any issues.
- Collaborate with local monitoring teams to ensure calibration documentation is available.
- May be assigned as the point of contact for studies internal/external audits in relation to logistics and supplies.
Requirements:
- Bachelor's degree in a relevant field (e.g., logistics, supply chain management, pharmaceutical sciences).
- Minimum 3 years of experience in clinical trial logistics or a related field.
- Familiarity with ICH GCP, GxP, and ICON SOPs.
- Ability to work independently and collaboratively as part of a global team.
- Strong problem-solving and analytical skills.
- Excellent communication and interpersonal skills.
Compensation:
The estimated annual salary for this position is around $85,000 - $110,000, depending on experience and qualifications.
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