Clinical Trial Materials
4 days ago
Role: Clinical Trial Materials
Location: Ideally Ireland but open to UK with occasional office presence
Our client is a large global healthcare company that specializes in producing plasma-derived medicines and other innovative solutions aimed at treating a variety of conditions. The company is a leader in plasma collection and manufacturing, focusing on therapies that support patients with chronic and rare diseases, immune deficiencies, and bleeding disorders.
It also has divisions dedicated to diagnostics, hospital pharmacy solutions, and biological product manufacturing, contributing to healthcare advancements across various fields.
Responsibilities:
Manages the global Clinical Trial Material (CTM) supply for clinical trials to ensure quality products are available at the right place and time to meet evolving study needs. Oversees a wide range of CTM tactical and project management activities throughout the clinical trial lifecycle, including forecasting and planning, cGMP clinical packaging, labeling, distribution, implementation and oversight of IVRS/IWRS systems for drug supply, global drug shipment management, and accountability/disposition of Investigational Medicinal Products (IMP).
Collaborates with internal and external regulatory, manufacturing, quality, and clinical teams to maintain smooth, responsive, and compliant operations. Ensures detailed oversight of clinical trial material projects within dynamic environments.
Primary Responsibilities:
- Manages and maintains appropriate levels of CTM study drug and supplies for assigned trials to ensure uninterrupted availability while adhering to quality standards, compliance, budget, and timelines.
- Initiates and tracks CTM shipments, receipts, depot inventories, site inventories, IVRS/IWRS functionality, expiry dates, packaging randomization codes, and drug accountability.
- Monitors CTM shipping and distribution activities, identifies issues or variances, and recommends solutions.
- Collaborates with the CTM manager and project management team to develop and execute trial-specific supply strategies.
- Participates in the development of IVRS/IWRS specifications for randomization and drug supply management or designs complex MS Excel models for manual supply management.
- Forecasts short-term and long-term clinical study drug, placebo, and ancillary supply needs for various protocol designs. Coordinates with internal and external stakeholders to ensure the timely manufacture and delivery of study materials.
Requirements:
- Background in Clinical Trial Materials Supplies Management
- Background in Clinical Operations preferred
- Knowledge of cGMPs, and other relevant clinical trial processes and regulations
- Experience with global clinical supplies management and IVRS/IWRS systems
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