Position Summary: The Project Support Associate provides administrative support to Project Managers for successful completion and supply maintenance over the life cycle of each project. Project support activities include task completion and issue resolution with internal customer procedures and support systems.
- Works with the Client and the internal project management team to finalize project specifications. This may include meetings either at Fisher Clinical Services or at the client’s premises.
- Assists in setting up and maintaining study filing systems and maintains accurate records for all work undertaken.
- Joint responsibility with the Project Manager for ensuring that all Fisher Clinical Services activities come together in a timely manner to meet the customer and study requirements.
- 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 customer.
- Use of appropriate project planning tools to communicate milestones and critical path activities and responsibilities.
- Timely provision of reports and other information to customers if applicable.
- Works with the Master Production Scheduler to optimize production of clinical supplies balancing the customer requirements with best use of available capacity.
- Creates and/ or supports creation of operational documentation using internal systems. Create bill of materials in GPM and coordinate creation and review of billing packages.
- Provides back-up support to the Project manager.
- Monitors project activities and day to day business and establishes a customer approved job specification,
- Collects all information on a study design including; correct label texts, coordination of primary, secondary packaging material and tools, coordination of label translation, producing all batch documentation for operations and check of documentation, coordination of shipments through the logistics department, and writing Distribution orders and GMP instructions in a timely manner.
- Applies Good Manufacturing Principles in all areas of responsibility.
- Requires understanding and competent use of SOPs required by company Quality standards.
- Requires excellent organizational, planning, verbal, written and numerical skills with the ability to analyze and define solutions and manage multiple tasks to meet strict deadlines.
- Requires strong and effective communicator with the ability to effectively present information and respond to questions from groups of managers and clients.
- Requires ability to develop strong customer management skills; proactively anticipates, understands, and responds to the needs of clients to meet or exceed their expectations.
- Requires ability to learn and master all internal systems associated with projects (i.e. Salesforce, GPMS, Trackwise).
- Prefer proficiency in appropriate project planning tools e.g. Microsoft Project to communicate milestones and critical path activities and responsibilities.
- Prefer in depth understanding of clinical trials.
- Prefer Certification in Project Management by a recognized institution in project
Work Conditions / Physical Requirements:
- Ability to work, on occasion, in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, marked changes in temperature.
- Must be able to lift and carry up to 50 lbs., on occasion
- Must be able to use a computer up to 8 hours per day.
- 10 - 25% Travel, as needed.