[Hiring] Forecasting and Resupply Lead @4g Clinical

Role Description

The 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, identifying opportunities for efficient, simple, and robust study resupply configurations.
  • Advise internal Prancer RTSM® implementation teams on design choices to align RTSM implementation with the 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 a subject matter expert, providing documented outcomes to support issue resolution and highlight improvement opportunities.
  • Work with clients to understand supply strategy, identify gaps in Prancer RTSM® resupply configuration or 4C-Supply model, and provide expert consultation on strategy optimization.
  • Proactively review Prancer RTSM® resupply and forecasting results to recommend improvements and avoid 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 communicate these to 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 forecasting and resupply theory and tasks (implementation operations, support operations, process and product improvement).

Qualifications

• Minimum of 5 years of experience in the clinical research field, particularly in 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.

Requirements

• At minimum a bachelor’s degree in a life sciences, supply chain management, or information technology field, or equivalent experience.

Benefits

• Compelling benefits for international and US-based employees, varying by region.

Company Description

4G Clinical is a global leader in randomization and trial supply management (RTSM) and supply forecasting optimization software for the life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solutions utilizing natural language processing (NLP) to accelerate clinical trials. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia.

4G Clinical is proud to be an Equal Opportunity Employer, ensuring all qualified applicants receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by applicable law.

Open to candidates in Belgium, Germany, Netherlands, Ireland & the UK.