Project Coordinator

OVERALL ROLE OBJECTIVE: The principle function of the Project Services department is the day-to-day management of all Almac Clinical Services customers at any Almac Clinical Services (ACS) site. The department coordinates all aspects of the delivery of a customer’s project as specified in the quotation. In order to achieve this, the department is divided into a customer support group which includes supply chain management and an operations support group. The operations support group is further divided into two key areas: production and distribution. The Project Coordinator working in production is responsible for performing all tasks associated with the successful management of the manufacture and packaging of clinical trial supplies at any Almac Clinical Services (ACS) site. The Project Coordinator working in distribution is responsible for performing all tasks associated with the successful management of the distribution and return of clinical trial supplies at any Almac Clinical Services (ACS) site. Project Coordinators provide a supportive role to the Project Distribution Lead or Project Production Lead.

JOB SPECIFIC RESPONSIBILITIES: Production

• Schedule operations with production planning to meet customer timelines
• Track the progress of operations against the project plan and advise the Project Production Lead of any issues or delays arising throughout the course of the project, escalating to the Project Team or Project Group Manager as appropriate
• Draft detailed written instructions for the manufacture/packaging of each batch of material ensuring full compliance with current Good Manufacturing Practice
• Provide timely information/documentation required for the management of the materials required for upcoming manufacturing operations.
• Track ordering and receipt of drug product and components for production activities, assisting Logistics and QC in the clearance upon receipt at Almac
• Expedite materials and documents through internal Almac systems
• Escalate project specific production issues to the project Team or the Project Group Manager as appropriate
• Calculate quantities of drug product and input components needed per production operation
• Allocate drug product and components to production jobs
• Track the progress of the production operations against the project plan and advise the Project Team of any issues affecting the planned production dates
• Schedule and gather documents for QP release of Almac produced finished goods
• Schedule analytical services to meet customer timelines
• Monitor inventory levels and expiry dates of components to ensure adequate levels of inventory are available for production operations
• Initiate the order for ancillary supplies and components for production operations as required ensuring that the appropriate approvals are obtained
• Assist in progressing rework of returned material per customer request
• Generate change requests for material receipt and production related documentation
• Assist in the generation of quality incident reports and technical queries relating to project specific production issues

Distribution

• Draft detailed distribution instructions and depot project instructions
• Draft instructions for return, accountability and destruction at Almac facilities and Almac contracted depots
• Establish distribution protocols in COSMOS to ensure accurate and complete set up of all items, Autoship, Depots, Returns, JIT, and distribution related activities.
• Schedule and gather documentation for QP release of customer supplied finished goods, scheduling analytical testing if required
• Ensure required lots of finished goods are released for shipment to the appropriate countries in advance of the first shipment date
• Complete protocol setup in the inventory release file (IRF) generator if applicable and generate Inventory Release Files for lot release.
• Set trigger levels, monitor inventory levels and expiry dates of shipping components (e.g. shippers, temp tales), ancillary supplies (e.g. syringes, dosing instructions/leaflets, alcohol swabs) and ancillary drug supplies (e.g. rescue medications) to ensure adequate levels of inventory are available for subsequent shipments from Almac warehouses and depots
• Notify the customer when inventory levels are low for customer supplied components and supplies
• Initiate the order for ancillary supplies and components supplied by Almac ensuring that appropriate approvals are obtained
• Monitor expiry dates of finished goods and notify the Clinical Supply Manager as required
• Arrange for shipment of samples to the customer or third party
• Generate memos providing instructions to the sites and depots on re-labelling activities and upon approval from the Clinical Supply Manager, assemble and distribute the notifications and materials for re-labelling to sites, depots and clinical monitors, tracking and reconciling the completion of the re-labelling activities
• Review and track the receipt of Drug Accountability Logs communicating with sites and/or clinical monitors as required ensuring that the logs are completed.
• Track destruction of returns and forward Certificates of Destruction to the customer
• Generate change requests for distribution and returns related documentation
• Assist in the generation of quality incident reports and technical queries relating to project specific distribution issues

Customer Service (All areas)

• Ensure all customer contact is carried out with a high level of professionalism in order to develop and maintain good working relationships with each customer
• Receive and follow through on all customer queries ensuring a response is supplied in a timely manner
• Attend teleconferences and meetings with customer as required
• Deal with customer complaints according to defined procedures and escalate to the Clinical Supply Manager as appropriate
• Maintain a professional approach at all times while representing Almac
• Fulfil any necessary administration duties required to assist the team
• Log all billable time against the correct project in the Timesheet system

Other (Operational)

• Provide support and act as the backup to the Project Distribution/Production Lead when requested for routine customer communication and project team updates
• Perform all tasks within the necessary timeframe defined for each project
• Provide regular updates to the Clinical Supply Manager for global projects when required
• Complete departmental Key Performance Indicators (KPIs) for specific projects as required

This role may require coverage beyond normal working hours on a regular basis. It is a condition of your employment that you are able to fulfil this requirement of the role. QUALIFICATIONS Educated to A-level standard (or equivalent) Currently studying a Business or Sciences based Degree qualification and have completed second year of your degree before commencing placement in Summer 2025 KEY SKILLS

Proficiency in the use of Microsoft Office packages (to include Outlook, Word, Excel and PowerPoint) Effective communication skills (verbal, written, presentational and interpersonal) Ability to work effectively on own initiative and effectively contribute within a team environment Proven ability to adopt a methodical approach, managing multiple tasks simultaneously whilst maintaining a high level of accuracy in all work carried out