RTSM Solutions Architect - Amendments
Description The Client Services Lead, Amendments is responsible for the following: System Implementation Expert implementation of configuration changes to 4G Clinical’s PRANCER technology, including: Primary responsibility for defining and managing project scope and implementing technical changes within agreed timelines and at the highest quality Partner with 4G Clinical Support Leads to manage the client relationship and ensure successful project implementation Provide change design consultation assistance to 4G Clinical Support Leads during ‘discovery’ phase, prior to formal project request or start-up Partner with 4G Clinical Validation team to complete project validation, ensuring study changes are fully tested, and related risk areas are regression tested Partner with 4G Clinical Integration team to ensure that required integration changes are correctly defined, tested and implemented Escalate mid-project scope changes to 4G Clinical Accounts team to ensure that associated client costs are appropriately assessed and managed Prepare all technical environments for internal and client use, including client UAT and production change implementation Ensure that required patient data changes in support of the system changes are defined, scripted and tested Product Development Identify opportunities for product enhancements and collaborate with product development to influence RTSM product feature development, prioritization, and strategy to ensure that the product meets client capability needs, improve the system’s efficiency and user-friendliness This JOB description should not be deemed all-inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs Requirements A minimum of 5 years (10 for senior) of experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT services delivery and eClinical systems implementation is preferred. The following skills are essential: knowledge 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 The candidate should possess at minimum a bachelor’s degree in a life sciences, supply chain management, or information technology field, or have equivalent experience. Summary 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.