Minimum 3 years in clinical research, focusing on clinical supplies operations and eClinical systems.
Over 7 years of relevant system implementation experience in a related industry is acceptable.
Experience in software implementation and testing within clinical research or supply chain.
Project management experience leading cross-functional teams is essential.
Knowledge of GCP, ICH GCP regulations, and 21 CFR Part 11 is a plus.
Bachelor's degree in life science, supply chain management, or IT, or equivalent experience.
Responsibilities
Serve as the primary client engagement contact for integration projects.
Lead client meetings and requirements discussions with support from the Integrations Analyst.
Maintain expertise in Prancer RTSM/Admin to ensure integration design aligns with study design.
Log, track, and resolve functional and technical issues during implementation.
Ensure adherence to deliverables and milestones as per SOP/WIs.
Drive project activities, including study testing and user acceptance testing (UAT).
Benefits
Opportunity to lead high-impact client integration projects.
Engage directly with clients and enhance project management skills.
Work with cutting-edge Prancer RTSM/Admin systems.
Collaborate with cross-functional teams in a dynamic environment.
Contribute to the improvement of clinical research processes.
Full Job Description
Description
Preferred Location is US East
Join 4G Clinical as an Integration Project Lead and lead client integration projects, ensuring smooth implementation of our Prancer RTSM/Admin systems. This role involves client engagement, managing project activities, and resolving issues, all while maintaining high-quality standards. Ideal candidates have experience in clinical supplies operations, eClinical systems, and project management.
Key Accountabilities of the Integrations Project Lead include the following:
Primary Client engagement contact for Integration projects
Leading client meetings and requirements discussions with support from the Integrations Analyst
Maintain knowledge of Prancer RTSM/Admin and serve as the SME ensuring integration design is compatible with Prancer study design
Logs, tracks and drives resolution of functional and technical issues discovered during implementation and prior to go-live
Ensures adherence to required deliverables and milestones as defined in applicable SOP/WIs
Drives project activities, including study testing and UAT
Requirements
The position requires a minimum of 3 years of experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT services delivery and eClinical systems and integrations implementation, or over 7 years of relevant system implementation experience in related industry.
Software implementation and testing experience required in clinical research or a supply chain related industry. Project management experience working with cross-functional business and technical teams as project lead is required.
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 is a plus.
Education and/or Certification Requirements
The candidate must possess at minimum a bachelor's degree in a life science, supply chain management, or information technology field, or equivalent experience.
About 4G Clinical
4G Clinical is a software company that provides cloud-based solutions for clinical trials. The company's platform, Prancer, uses natural language processing and machine learning to automate the design, randomization, and supply chain management of clinical trials. Prancer also provides real-time analytics and reporting to help clinical trial sponsors make data-driven decisions. 4G Clinical was founded in 2015 and is headquartered in Medford, Massachusetts.
