Covance are looking to hire a Senior Specialist, Clinical and Ancillary Supplies services, the position can be based at our offices in Bulgaria (Sofia), Hungary (Budapest) or Ukraine (Kiev).

The Clinical & Ancillary Supplies Services (CASS) Senior Specialist:Coordinate and oversee aspects of logistics related to Clinical and Ancillary Supplies services.   Support these services to both internal and external clients.

• Responsible for the set-up and coordination of project activities related to clinical and ancillary supplies Independently support the delivery of the Clinical and Ancillary supplies component of assigned studies within a region or for a large global study.
• Provide local support with clinical and ancillary supplies start up activities and related project feasibility Act as a subject matter expert (SME) related to import, export and labeling requirements.
• Work with staff in Clinical Trial Design & Strategy, Vendor Management, Quality Assurance, Business Development and Operations, to provide relevant clinical and ancillary supply data critical to the ability of the organization to develop plans for the successful implementation and conduct of global clinical trials.
• Assure that pre-study, drug supply and labeling processes comply with applicable guidelines and regulations and fulfill client and Covance requirements. Provide logistical support for clinical and ancillary supply coordination
• Provide input into business development activities Act as a subject matter expert (SME) in client focused clinical and ancillary supply work streams

Experience required;

• University/College Degree (preferably postgraduate degree) AND clinical research/GMP experience
• Thorough understanding of global drug development and the clinical trial project management process, with a special emphasis on investigator sites, patient recruitment and retention
• Thorough and practical working knowledge of ICH-GCP Guidelines, Clinical GMP, including relevant international requirements/guidelines for the conduct of global clinical development programs Ideally
• Experience in Clinical Supply distribution/ GMP environment Relevant clinical research experience in a pharmaceutical company/CRO, including at least 2 years of clinical and ancillary supplies management responsibility.
• Very strong technical writing skills and analytical skills Preferred:
• 2-4 years Clinical Supply Project Management logistics experience Demonstrated Regulatory, GMP or QA experience.