Job Overview:

The Clinical and Ancillary Supplies Services (CASS) Specialist II: 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 and ancillary supply distribution strategy for the assigned region or for a simple global study. 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, provide input to project specific and Fortrea policies and procedures.
• Develop project specific plans for the Clinical and Ancillary supply component of assigned studies.
• Represent Clinical and Ancillary supplies component within a region or for a simple global study 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 region.
• Review the protocol to confirm if Fortrea/ other vendor can import all the supplies required in the region.
• As necessary, provide information 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(s).
• As appropriate, support payment process to the couriers and brokers in each of the participating countries in the designated region(s).
• As appropriate review commercial invoices and airway bills according to each individual shipment and country.
• Update the Importation Process for the region(s) as needed.
• Liaise with all the operational groups (Project Management, Clin Ops, GSS, GRS) at Fortrea in order to provide status reports.
• Work with GRS on obtaining, understanding, and interpreting country-specific requirements and regulations for the importation of clinical trial 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 regions 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 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.
• In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 5 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations will be considered.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Language Skills Required:
• Speaking: English + local language.
• Writing/Reading: English + local language.

Experience (Minimum Required):

• 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.
• Detail and process oriented.
• Positive attitude and approach.
• Multi-tasking capability.
• Ability to work independently.

Preferred Qualifications Include:

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

Physical Demands/Work Environment:

• General Office Environment.
• Travel Requirements:
• International and Domestic travel may be required up to 10% of the time, including air travel and overnight stays.
• Ability to drive and possess a valid driver’s license.
• Ability and willingness to present at internal and external meetings.

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