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Clinical Trial Supply Manager
2 settimane fa
Nouscom is a biotechnology company developing next generation cancer vaccines based on viral vector technologies that have advances in clinical trials. We are looking for a Full-Time **Clinical Trial Supply Manager** to join our Company.
**Clinical Trial Supply Manager **will support the Team in Delivery of Clinical Trial Supplies for Clinical Programs on time and on budget and successful management and oversight of Clinical Trial Supplies vendors.
Job Requirements:
- Minimum Requirements_
- Relevant university degree or educational experience
- 3+ years pharmaceutical industry experience within clinical operations preferred
- Management experience in global clinical trial supplies and associated regulatory requirements
- Project management and budget experience
- Experience in coordinating clinical trial materials, labelling, packaging and distribution to trial centers
- Knowledge of the drug development process and clinical development planning
- Successful experience in coordinating internal and external resources and in working with pharmaceutical partners
- Direct hands-on experience in managing high-quality successful clinical supply chain
- Fluent in English, Italian is a plus
- Preferred Requirements_
- Excellent verbal and written communication skills
- Clinical and operational knowledge, with continuous expansion and learning ability
- Works effectively in cross-functional teams
- Able to interact productively and effectively convince others
- Displays strong organization and time management skills; reliable in completing tasks and delivering on commitments in a timely manner
- High ethical standards and integrity
**Responsibilities**:
Provide oversight of all activities in the clinical supply chain to include: manufacturing / ordering of IMP supplies, packaging, labelling, distribution, blinding, randomization, import/export licensing, tracking systems, drug release documents, quality control/assurance, returns.
Conduct and oversee all supply chain activities and document design (labelling) according to SOPs, cGCPs, cGMPs, and all applicable regulations.
Liaise with and oversee Clinical vendors for management of clinical supplies in compliance with appropriate regulations.
Work with Clinical Trial Managers to formulate and prioritize short
- and long-term objectives with respect to clinical supplies and implement strategies to meet these objectives.
Ensure clinical trial supplies are ordered, managed, and delivered within agreed budget and timelines.
Work with Clinical Operations team in preparing and modifying timelines for clinical trial supply chain activities.
Support the development and implementation of processes and standards and providing a source of process improvement targets and ideas.
Maintain relationships with pharmaceutical partners and their CTS groups.
Work with Logistics / Supply Chain and QA team in developing and implementing process improvement plans and structure in relation to clinical trial supply management.
Ensure appropriate, comprehensive and professional communications both internally and externally.
Participate in Clinical Study Team meetings to provide Clinical Trial Supply status updates and expert advice.
Position based in Rome.
Contratto di lavoro: Tempo pieno
Orario:
- Turno diurno
