Clinical & Ancillary Supplies Services Specialist

Covance are looking to hire a Clinical & Ancillary Supplies Services (CASS) Specialist II, this role can be based at our offices in Kiev, Sofia or Budapest.

Responsibilities;

• Independently support the delivery of the Clinical and Ancillary supplies component of assigned studies within a region or for a simple global study.
• Act as contact with study team during clinical and ancillary start-up activities including input to the development of Clinical Trial Supplies Plan or Clinical Trial Supply Flow for a given group of countries in a region or within a region or for a simple global study.
• Perform and coordinate label review and country translations according to set procedures
• Responsible for working with project team to ensure the required documents and processes related to supply management are communicated and obtained. Where appropriate be the key contact for importation logistics and document exchange to ensure smooth clinical supply transportation arrangements are agreed and set up.
• Provide consultancy with regard to clinical & ancillary supply distribution strategy for the assigned region or for a simple global study.
• Responsible for maintenance of project specific clinical & ancillary supply logistics.
• Work closely with drug and ancillary supply distribution, IVRS/IRT and label translation vendors during the set up and maintenance of related logistics

Required: University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 3 years work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and FDA, GMP regulations.

• Minimum of 3 years relevant clinical research experience in a pharmaceutical company/CRO, including at least 1 year of clinical and ancillary supplies management responsibility.

• Working knowledge of ICH, FDA, GMP and other applicable regulations/guidelines; familiarity with clinical supply related documents
• Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
• Good organizational and time management skills
• Excellent communication / writing skills Strong computer skills with an ability to access and leverage technology alternatives
• Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies
• Self-motivation with the ability to work under pressure to meet deadlines
• Works well independently as well as in a team environment