Assessment of clinical protocol and other client supplied study specifications in conjunction with Proposals Group, FACTS Technical Group, Clinical Supplies, Operations and Procurement to help design Supply Chain solutions to meet the needs of the trial. Provision of data and technical input to the Proposals group to help them in the creation of proposal.
Working with the client to finalize logistics requirements. This may include Project meetings at the client site or at Fisher.
Coordination and communication of all relevant activities, both internal and external to ensure that all services and products are ready for the start of the study or as required by the client.
Overall responsibility for ensuring that activities come together in a timely manner to meet the client and study requirements.
Use of appropriate project planning tools e.g. Microsoft Project to communicate milestones and critical path activities and responsibilities.
Timely provision of reports and other information to clients.
Organization and delivery of training, including cross training of other members of Fisher where appropriate.
Provide input into the writing and review of departmental SOPs.
Participation in client meetings / bid support meetings / teleconferences, where appropriate.
Conduct training at Monitor / Investigator meetings as required by client.
Import Licenses-Design PF’s with Clients
Invoicing - As requested, provides revenue data for submission to Finance.
Revenue/Revenue recognition - Monitor and record change in the scope of contracts. Arrange for additional invoicing as required. Ensure accurate and regular invoicing is completed
Client/Site Enquiry management - Receipt of study related calls – issues, log calls in Trackwise system follow escalation procedure as appropriate. Monitor call logging system to ensure calls are closed out in a timely manner.
Assignment of Inventory data - Requests assignment of component and receiving lot numbers to the Inventory system
Good Manufacturing Practice - Investigates and reports on internal non-conformances. Assists others in investigations to issues not relevant to assigned studies.
Accuracy - Responsible for ensuring a high degree of accuracy within the Distribution process.
Receipt of study materials - Co-ordinate receipt of finished goods deliveries from clients
19. Participation in cross-functional business process improvement activities as required.