Clinical & Ancillary Supplies Services

Job Overview:

The Clinical and Ancillary Supplies Services (CASS) Specialist I: Support the delivery of the Clinical and Ancillary supplies component of assigned studies within a country or 1 region. 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. Perform and coordinate label review and country translations according to set procedures for a global study. 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 and ancillary supply distribution strategy for the assigned country(ies) in a region. Responsible for maintenance of project specific clinical and 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.

Summary of Responsibilities:

• Understand and follow project specific and Fortrea policies and procedures.
• Support the development of project specific plans for the Clinical and Ancillary supply component of assigned studies.
• Represent Clinical and Ancillary supplies component for country(ies) in the region at client and internal project meetings.
• Liaise with operational project team regarding project issues (i.e., participate in team meetings).
• Liaise with Sponsor and Fortrea regulatory regarding clinical supply related submission requirements.
• Attend ongoing training, project specific requirements and as may generally be required.
• Provide milestone information for the country(ies) in the region.
• Review the protocol to confirm if Fortrea / other vendor can import all the supplies required.
• As necessary, provide support to GRS to request import licenses and manage these import licenses as needed for the protocol.
• Coordinate and track shipments to sites required for each protocol as appropriate in the region.
• As appropriate, manage and communicate with the couriers and brokers in each of the participating countries in the designated region.
• As appropriate, support payment process to the couriers and brokers in each of the participating countries in the designated region.
• As appropriate review commercial invoices and airway bills according to each individual shipment and country.
• Update the Importation Process for each respective country in the region as needed.
• Liaise with all the operational groups (Project Management, Clin Ops, GSS, GRS) at Fortrea in order to provide status reports for import process.
• Work with GRS on obtaining, understanding, and interpreting country-specific requirements and regulations for the importation of CT supplies.
• Perform administrative tasks required during study start up activities (e.g., word processing, assembly of study documents, mass mailings, filing, faxing/photocopying).
• Manage the country / regional drug supply vendor activities as applicable.
• Oversee importation logistics and document exchange to ensure smooth clinical supply transportation arrangements are agreed and set up.
• Develop, review, and approve drug supply labels as applicable.
• Coordinate ancillary supply logistics with various vendors or internal team.
• Independently research and evaluate proposal request from clients in all therapeutic areas within agreed timeframes.
• Assist with preparation of materials for formal client/industry presentations and for internal training assignments.
• Conduct QC of documents as required by the process.
• Undertake literature and internet searches as required.
• Mentor other team members.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• University/College degree (life science preferred), or certification in a related allied health profession
• English level: Advanced/ fluent

Experience (Minimum Required):

• Minimum of 2 years relevant clinical research experience in a pharmaceutical company/CRO, including at least 1 year of clinical and ancillary supplies management responsibility.
• Advanced English level
• 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.
• Works well independently as well as in a team environment.
• Detail and process oriented.
• Multi-tasking capability.

Preferred Qualifications Include:

• 2 years’ Experience in Clinical Supply distribution/ GMP environment.

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