Open to candidates in the Belgium, Germany, Netherlands, Ireland & the UK
Key Accountabilities of the Forecasting and Resupply Lead include the following:
Implementation Operations
- Implement 4C-Supply applications to enable start-up targets for clients’ clinical research studies.
- Advise clients and internal Prancer RTSM® implementation teams (new builds and changes) on forecasting plan development and documentation, thereby identifying and highlighting opportunities to achieve study resupply configurations which are as efficient, simple and robust as possible.
- Advise internal Prancer RTSM® implementation teams on design choices which facilitate the alignment between RTSM implementation and 4C-Supply model.
- Implement integrations of RTSM data to 4C-Supply according to 4G Clinical SOPs and WIs.
- Participate in system validation and/or user acceptance testing on request.
Support Operations
- Investigate Prancer RTSM® resupply and forecasting issues as subject matter expert on request, providing investigation outcomes which are accurately and comprehensively documented and which support successful issue resolution and highlight opportunities to improve study resupply and forecasting configuration.
- Work with clients on their clinical research studies to understand the supply strategy, any gaps in the current Prancer RTSM® resupply configuration or current 4C-Supply model and provide expert consultation on strategy and/or settings optimization.
- Proactively review Prancer RTSM® resupply and forecasting results to recommend opportunities for improvement and avoiding stock-out situations.
- Manage sponsor communication on resupply and forecasting, providing troubleshooting support and explaining outcomes.
- Train clients and internal teams on forecasting and resupply theory, working with 4G Clinical tools and optimizing supply strategies and settings.
- Participate in client audits on request.
Process and Product Improvement
- Suggest and participate in forecasting and resupply implementation and support process improvement projects.
- Identify operational business needs for product improvements related to forecasting and resupply and bring these to the attention of the product management team.
- Participate in requirements gathering of product improvements on request.
- Participate in testing of product improvements on request and provide feedback.
Further Support
- Support other teams (e.g., Commercial Operations, Marketing, Training, Quality) in questions and projects related to forecasting and resupply.
- Train FRS team members on background (forecasting and resupply theory, working with 4G Clinical tools and optimizing supply strategies and settings) and tasks (implementation operations, support operations, process and product improvement).
- Minimum of 5 years of experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT services delivery, clinical supplies forecasting/simulation services delivery and/or eClinical systems implementation.
- Knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH)
- GCP regulations, Electronic Records; Electronic Signatures regulation (21 CFR Part 11) and EU Annex 11, and associated regulatory guidance documents.
Education and/or Certification Requirements
At minimum a bachelor’s degree in a life sciences, supply chain management, or information technology field, or equivalent experience.
