Description

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

REQUIRED EXPERIENCE

• 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.

OTHER SKILLS/REQUIREMENTS

• Clinical supplies forecasting and management experience is highly desired.
• Experience with IRT/RTSM and clinical supplies forecasting/simulation tools is a plus.
• Experience working with agile development methodology is a plus.
• Leadership Competencies; Client focused, solutions focused, proactive, responsive, organized, highest quality deliverables.
• Excellent verbal and written communication skills.