Forecasting and Resupply Lead

Forecasting and Resupply Lead 4G Clinical, LLC - 5.0 Wellesley, MA Job Details Full-time 1 day ago Benefits Disability insurance Dental insurance 401(k) Flexible spending account Vision insurance Sabbatical Life insurance Qualifications

FDA 21 CFR

Part 11 ICH guidelines Clinical research compliance Supply chain management solutions (enterprise solutions) Full Job Description 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 (10 for senior) 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. 4G Clinical is honored to be part of Fast Company's 2020 Best Workplaces for Innovators list, citing businesses and organizations that demonstrate a deep commitment to encouraging innovation at all levels. 4G Clinical came in at #8 for its dedication to building a culture that fuels innovation, curiosity, and the spirit of experimentation in all facets of the business from product development and brand to services and staffing. We were also voted one of the 2018 Best Places in Health Care & Biopharma by Great Place to Work® and FORTUNE. About Us 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. For U.S.-based candidates, we offer compelling benefits to our employees, including: Health, dental, and vision benefits Unlimited Vacation Days for Salaried Full-time Employees FSA and Dependent Care Accounts Company Paid Disability and Life Insurance Global mental health benefit Generous 401k program Paid sabbatical program Option Grants 4G Clinical is proud to be an Equal Opportunity Employer, and it is foundational to how we recruit and hire our talented team. All qualified applicants will 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.